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Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery

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ClinicalTrials.gov Identifier: NCT01989572
Recruitment Status : Completed
First Posted : November 21, 2013
Results First Posted : August 12, 2014
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Iris Melanoma
Medium/Large Size Posterior Uveal Melanoma
Mucosal Melanoma
Ocular Melanoma With Extraocular Extension
Recurrent Melanoma
Recurrent Uveal Melanoma
Small Size Posterior Uveal Melanoma
Stage IIA Cutaneous Melanoma AJCC v6 and v7
Stage IIA Uveal Melanoma AJCC v7
Stage IIB Cutaneous Melanoma AJCC v6 and v7
Stage IIB Uveal Melanoma AJCC v7
Stage IIC Cutaneous Melanoma AJCC v6 and v7
Stage IIIA Cutaneous Melanoma AJCC v7
Stage IIIA Uveal Melanoma AJCC v7
Stage IIIB Cutaneous Melanoma AJCC v7
Stage IIIB Uveal Melanoma AJCC v7
Stage IIIC Cutaneous Melanoma AJCC v7
Stage IIIC Uveal Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Stage IV Uveal Melanoma AJCC v7
Interventions Other: Laboratory Biomarker Analysis
Other: Placebo
Biological: Sargramostim
Biological: Tyrosinase Peptide
Enrollment 815
Recruitment Details The study was open between December 29, 1999 and October 31, 2006. A total of 815 patients were enrolled.
Pre-assignment Details  
Arm/Group Title Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo)
Hide Arm/Group Description

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide vaccine: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

peptide vaccine: Given SC

GM-CSF placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide placebo: Given SC

Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

GM-CSF placebo: Given SC

peptide placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14.

sargramostim: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.

GM-CSF placebo: Given SC

Period Title: Overall Study
Started 109 111 109 107 190 189
Treated 104 110 107 104 186 171
Completed 54 53 47 56 92 79
Not Completed 55 58 62 51 98 110
Reason Not Completed
Lack of Efficacy             35             48             48             43             71             79
Adverse Event             2             1             3             0             3             0
Death             0             0             0             0             1             0
Withdrawal by Subject             4             1             5             1             12             4
complicating disease             1             1             2             0             1             0
error             2             1             1             1             1             1
maximum dose reached             0             1             0             0             1             0
unknown/not specify             3             4             1             3             3             5
not start protocol therapy             5             1             2             3             4             18
alternative therapy             3             0             0             0             1             3
Arm/Group Title Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo) Total
Hide Arm/Group Description

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide vaccine: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

peptide vaccine: Given SC

GM-CSF placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide placebo: Given SC

Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

GM-CSF placebo: Given SC

peptide placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14.

sargramostim: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.

GM-CSF placebo: Given SC

Total of all reporting groups
Overall Number of Baseline Participants 109 111 109 107 190 189 815
Hide Baseline Analysis Population Description
All patients regardless of eligibility and treatment status
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 109 participants 111 participants 109 participants 107 participants 190 participants 189 participants 815 participants
60
(27 to 83)
56
(22 to 82)
57
(23 to 87)
58
(23 to 82)
60
(19 to 88)
57
(19 to 87)
58
(19 to 88)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 109 participants 111 participants 109 participants 107 participants 190 participants 189 participants 815 participants
Female 48 45 45 39 77 77 331
Male 61 66 64 68 112 112 483
[1]
Measure Description: One patient on arm V had missing data for gender. Hence, a total of 189 patients on arm V reported gender.
1.Primary Outcome
Title Overall Survival
Hide Description Overall survival is defined as time from randomization to death from any cause.
Time Frame assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients, regardless of eligibility
Arm/Group Title GM-CSF GM-CSF Placebo
Hide Arm/Group Description:
Patients received GM-CSF in the trial, including patients on arms I, III, V.
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
Overall Number of Participants Analyzed 408 407
Median (95% Confidence Interval)
Unit of Measure: months
69.6
(53.4 to 83.5)
59.3
(44.4 to 77.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GM-CSF, GM-CSF Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.528
Comments [Not Specified]
Method Log Rank
Comments stratifying on HLA-A2 status, site of metastases and number of metastatic lesions.
2.Primary Outcome
Title Recurrence Free Survival
Hide Description Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Time Frame assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients, regardless of eligibility
Arm/Group Title GM-CSF GM-CSF Placebo
Hide Arm/Group Description:
Patients received GM-CSF in the trial, including patients on arms I, III, V.
Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
Overall Number of Participants Analyzed 408 407
Median (95% Confidence Interval)
Unit of Measure: months
11.4
(9.4 to 14.8)
8.8
(7.5 to 11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GM-CSF, GM-CSF Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method Log Rank
Comments stratifying on HLA-A2 status, site of metastases, and number of metastatic lesions
3.Secondary Outcome
Title Overall Survival in Human Leukocyte Antigens-A2 (HLA-A2) Positive Patients
Hide Description Overall survival is defined as time from randomization to death from any cause.
Time Frame assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years,up to year 15
Hide Outcome Measure Data
Hide Analysis Population Description
all HLA-A2 positive patients
Arm/Group Title Peptide Vaccination Peptide Placebo
Hide Arm/Group Description:
Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
Overall Number of Participants Analyzed 220 216
Median (95% Confidence Interval)
Unit of Measure: months
68.6
(47.0 to 92.3)
63.3
(49.2 to 105.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peptide Vaccination, Peptide Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Log Rank
Comments stratifying on GM-CSF, site of metastases and number of metastatic lesions
4.Secondary Outcome
Title Recurrence Free Survival in HLA-A2 Positive Patients
Hide Description Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Time Frame assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Hide Outcome Measure Data
Hide Analysis Population Description
all HLA-A2 positive patients
Arm/Group Title Peptide Vaccination Peptide Placebo
Hide Arm/Group Description:
Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
Overall Number of Participants Analyzed 220 216
Median (95% Confidence Interval)
Unit of Measure: months
11.5
(8.7 to 20.4)
9.8
(7.7 to 15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Peptide Vaccination, Peptide Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments stratifying on GM-CSF, site of metastases and number of metastatic lesions
Method Log Rank
Comments [Not Specified]
5.Secondary Outcome
Title 5-year Overall Survival Rate
Hide Description Overall survival is defined as time from randomization to death from any cause, and 5-year overall survival rate is estimated via Kaplan-Meier method.
Time Frame assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients, regardless of eligibility
Arm/Group Title Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo)
Hide Arm/Group Description:

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide vaccine: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

peptide vaccine: Given SC

GM-CSF placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide placebo: Given SC

Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

GM-CSF placebo: Given SC

peptide placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14.

sargramostim: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.

GM-CSF placebo: Given SC

Overall Number of Participants Analyzed 109 111 109 107 190 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
55.5
(45.4 to 64.5)
51.9
(42.0 to 61.0)
51.1
(41.2 to 60.1)
51.6
(41.4 to 60.9)
51.2
(43.8 to 58.2)
46.7
(39.3 to 53.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (GM-CSF, Peptide Vaccine), Arm II (GM-CSF Placebo, Peptide Vaccine), Arm III (GM-CSF, Peptide Placebo), Arm IV (GM-CSF Placebo, Peptide Placebo)
Comments Treatment arm comparison in patients with positive HLA-A2 status
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method Log Rank
Comments stratifying on site of metastases and number of metastatic lesions
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm V (GM-CSF), Arm VI (GM-CSF Placebo)
Comments Treatment arm comparison in patients with negative HLA-A2 status
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Log Rank
Comments stratifying on site of metastases and number of metastatic lesions
6.Secondary Outcome
Title 5-year Recurrence Free Survival Rate
Hide Description Recurrence free survival is defined as time from randomization to first disease recurrence or death from any cause (whichever occur first), censoring cases without recurrence or death at the last date of known free of recurrence free survival events, and 5-year overall survival rate is estimated via Kaplan-Meier method. Disease recurrence was determined based on positive cytology or biopsy in the presence of a single new lesion or the appearance of multiple lesions consistent with metastatic disease, or a positive brain CT or MRI scan or CSF cytology.
Time Frame assessed every 3 months if patient is < 2 years from study entry and every 6 months if patient is 2-5 years from study entry, and annually if >5 years, up to year 15
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients, regardless of eligibility
Arm/Group Title Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo)
Hide Arm/Group Description:

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide vaccine: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

peptide vaccine: Given SC

GM-CSF placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC

peptide placebo: Given SC

Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

GM-CSF placebo: Given SC

peptide placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14.

sargramostim: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.

GM-CSF placebo: Given SC

Overall Number of Participants Analyzed 109 111 109 107 190 189
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
32.4
(23.6 to 41.5)
33.2
(24.4 to 42.2)
31.3
(22.8 to 40.2)
28.0
(19.7 to 36.9)
30.6
(24.1 to 37.3)
22.9
(17.1 to 29.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (GM-CSF, Peptide Vaccine), Arm II (GM-CSF Placebo, Peptide Vaccine), Arm III (GM-CSF, Peptide Placebo), Arm IV (GM-CSF Placebo, Peptide Placebo)
Comments Treatment arm comparison in patients with positive HLA-A2 status
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Log Rank
Comments stratifying on site of metastases and number of metastatic lesions
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm V (GM-CSF), Arm VI (GM-CSF Placebo)
Comments Treatment arm comparisons in patients with negative HLA-A2 status
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Log Rank
Comments stratifying on site of metastases and number of metastatic lesions
Time Frame Assessed every cycle (1 cycle=28 days) for cycles 1, 2, 3, and 4; after cycle 4, assessed every 3 months (at the completion of cycles 7, 10, 13) while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description After off treatment, if the patient experienced any clinical problems possibly related to the protocol treatment, the clinical problems were also reported per the standard ECOG follow-up schedule: every 3 months if patient is <2 years from study entry, every 6 months if patient is 2-5 years from study entry, and every 12 months if >5 years.
 
Arm/Group Title Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo)
Hide Arm/Group Description

Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC peptide vaccine: Given SC

Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

peptide vaccine: Given SC GM-CSF placebo: Given SC

Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

sargramostim: Given SC peptide placebo: Given SC

Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).

GM-CSF placebo: Given SC peptide placebo: Given SC

Patients receive GM-CSF (sargramostim) SC on days 1-14.

sargramostim: Given SC

Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.

GM-CSF placebo: Given SC

All-Cause Mortality
Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/104 (11.54%)   17/110 (15.45%)   15/107 (14.02%)   9/104 (8.65%)   22/186 (11.83%)   12/171 (7.02%) 
Blood and lymphatic system disorders             
Anemia  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  1/104 (0.96%)  0/186 (0.00%)  1/171 (0.58%) 
Cardiac disorders             
Cardiac disorders - Other, specify  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  1/104 (0.96%)  0/186 (0.00%)  0/171 (0.00%) 
Myocardial infarction  1  1/104 (0.96%)  0/110 (0.00%)  1/107 (0.93%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Gastrointestinal disorders             
Nausea  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Diarrhea  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Abdominal pain  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
General disorders             
Fatigue  1  0/104 (0.00%)  0/110 (0.00%)  3/107 (2.80%)  0/104 (0.00%)  1/186 (0.54%)  1/171 (0.58%) 
Injection site reaction  1  2/104 (1.92%)  9/110 (8.18%)  2/107 (1.87%)  2/104 (1.92%)  1/186 (0.54%)  1/171 (0.58%) 
Non-cardiac chest pain  1  0/104 (0.00%)  0/110 (0.00%)  1/107 (0.93%)  0/104 (0.00%)  2/186 (1.08%)  0/171 (0.00%) 
Pain  1  0/104 (0.00%)  0/110 (0.00%)  1/107 (0.93%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Immune system disorders             
Anaphylaxis  1  1/104 (0.96%)  1/110 (0.91%)  1/107 (0.93%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Flushing  1  0/104 (0.00%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Infections and infestations             
Infections and infestations - Other, spe  1 [1]  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Infections and infestations - Other, spe  1 [2]  0/104 (0.00%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Infections and infestations - Other, spe  1 [3]  1/104 (0.96%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Investigations             
White blood cell decreased  1  0/104 (0.00%)  0/110 (0.00%)  2/107 (1.87%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Neutrophil count decreased  1  0/104 (0.00%)  2/110 (1.82%)  2/107 (1.87%)  2/104 (1.92%)  2/186 (1.08%)  2/171 (1.17%) 
Weight gain  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Weight loss  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  1/104 (0.96%)  0/186 (0.00%)  0/171 (0.00%) 
Blood bilirubin increased  1  0/104 (0.00%)  1/110 (0.91%)  2/107 (1.87%)  3/104 (2.88%)  2/186 (1.08%)  2/171 (1.17%) 
Aspartate aminotransferase increased  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Creatinine increased  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  1/104 (0.96%)  1/186 (0.54%)  1/171 (0.58%) 
Musculoskeletal and connective tissue disorders             
Arthritis  1  0/104 (0.00%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Musculoskeletal and connective tissue di  1  1/104 (0.96%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Arthralgia  1  0/104 (0.00%)  1/110 (0.91%)  4/107 (3.74%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Myalgia  1  0/104 (0.00%)  2/110 (1.82%)  1/107 (0.93%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Nervous system disorders             
Dizziness  1  0/104 (0.00%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Nervous system disorders - Other, specif  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Peripheral motor neuropathy  1  0/104 (0.00%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  0/186 (0.00%)  1/171 (0.58%) 
Peripheral sensory neuropathy  1  0/104 (0.00%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Syncope  1  1/104 (0.96%)  0/110 (0.00%)  1/107 (0.93%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Headache  1  3/104 (2.88%)  0/110 (0.00%)  0/107 (0.00%)  1/104 (0.96%)  6/186 (3.23%)  0/171 (0.00%) 
Psychiatric disorders             
Insomnia  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Depression  1  0/104 (0.00%)  0/110 (0.00%)  0/107 (0.00%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Dyspnea  1  0/104 (0.00%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  3/186 (1.61%)  0/171 (0.00%) 
Skin and subcutaneous tissue disorders             
Pruritus  1  0/104 (0.00%)  0/110 (0.00%)  1/107 (0.93%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Rash maculo-papular  1  2/104 (1.92%)  1/110 (0.91%)  1/107 (0.93%)  0/104 (0.00%)  2/186 (1.08%)  0/171 (0.00%) 
Urticaria  1  1/104 (0.96%)  1/110 (0.91%)  0/107 (0.00%)  0/104 (0.00%)  1/186 (0.54%)  0/171 (0.00%) 
Vascular disorders             
Thromboembolic event  1  1/104 (0.96%)  0/110 (0.00%)  1/107 (0.93%)  0/104 (0.00%)  0/186 (0.00%)  0/171 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 2.0
[1]
infection with grade 3 or 4 neutropenia
[2]
infection with unknown ANC
[3]
infection w/o neutropenia
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I (GM-CSF, Peptide Vaccine) Arm II (GM-CSF Placebo, Peptide Vaccine) Arm III (GM-CSF, Peptide Placebo) Arm IV (GM-CSF Placebo, Peptide Placebo) Arm V (GM-CSF) Arm VI (GM-CSF Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   104/104 (100.00%)   109/110 (99.09%)   105/107 (98.13%)   102/104 (98.08%)   180/186 (96.77%)   143/171 (83.63%) 
Blood and lymphatic system disorders             
Anemia  1  21/104 (20.19%)  15/110 (13.64%)  26/107 (24.30%)  18/104 (17.31%)  25/186 (13.44%)  16/171 (9.36%) 
Cardiac disorders             
Cardiac disorders - Other, specify  1  6/104 (5.77%)  4/110 (3.64%)  9/107 (8.41%)  7/104 (6.73%)  6/186 (3.23%)  5/171 (2.92%) 
Gastrointestinal disorders             
Nausea  1  24/104 (23.08%)  24/110 (21.82%)  21/107 (19.63%)  15/104 (14.42%)  36/186 (19.35%)  19/171 (11.11%) 
Vomiting  1  6/104 (5.77%)  5/110 (4.55%)  5/107 (4.67%)  4/104 (3.85%)  8/186 (4.30%)  3/171 (1.75%) 
Diarrhea  1  16/104 (15.38%)  8/110 (7.27%)  11/107 (10.28%)  11/104 (10.58%)  27/186 (14.52%)  19/171 (11.11%) 
Abdominal pain  1  3/104 (2.88%)  2/110 (1.82%)  3/107 (2.80%)  3/104 (2.88%)  11/186 (5.91%)  6/171 (3.51%) 
General disorders             
Fatigue  1  67/104 (64.42%)  53/110 (48.18%)  58/107 (54.21%)  57/104 (54.81%)  81/186 (43.55%)  66/171 (38.60%) 
Fever  1  17/104 (16.35%)  19/110 (17.27%)  15/107 (14.02%)  6/104 (5.77%)  21/186 (11.29%)  13/171 (7.60%) 
Chills  1  24/104 (23.08%)  13/110 (11.82%)  14/107 (13.08%)  7/104 (6.73%)  24/186 (12.90%)  12/171 (7.02%) 
General disorders and administration sit  1  5/104 (4.81%)  6/110 (5.45%)  6/107 (5.61%)  5/104 (4.81%)  8/186 (4.30%)  5/171 (2.92%) 
Injection site reaction  1  99/104 (95.19%)  100/110 (90.91%)  98/107 (91.59%)  89/104 (85.58%)  147/186 (79.03%)  43/171 (25.15%) 
Non-cardiac chest pain  1  0/104 (0.00%)  1/110 (0.91%)  3/107 (2.80%)  0/104 (0.00%)  10/186 (5.38%)  1/171 (0.58%) 
Pain  1  8/104 (7.69%)  9/110 (8.18%)  5/107 (4.67%)  10/104 (9.62%)  10/186 (5.38%)  11/171 (6.43%) 
Injury, poisoning and procedural complications             
Bruising  1  1/104 (0.96%)  4/110 (3.64%)  0/107 (0.00%)  6/104 (5.77%)  3/186 (1.61%)  4/171 (2.34%) 
Investigations             
White blood cell decreased  1  7/104 (6.73%)  9/110 (8.18%)  8/107 (7.48%)  12/104 (11.54%)  7/186 (3.76%)  13/171 (7.60%) 
Neutrophil count decreased  1  3/104 (2.88%)  10/110 (9.09%)  5/107 (4.67%)  10/104 (9.62%)  8/186 (4.30%)  11/171 (6.43%) 
Platelet count decreased  1  6/104 (5.77%)  4/110 (3.64%)  8/107 (7.48%)  2/104 (1.92%)  5/186 (2.69%)  6/171 (3.51%) 
Weight gain  1  7/104 (6.73%)  6/110 (5.45%)  6/107 (5.61%)  10/104 (9.62%)  7/186 (3.76%)  8/171 (4.68%) 
Weight loss  1  2/104 (1.92%)  7/110 (6.36%)  5/107 (4.67%)  6/104 (5.77%)  8/186 (4.30%)  8/171 (4.68%) 
Alkaline phosphatase increased  1  7/104 (6.73%)  5/110 (4.55%)  3/107 (2.80%)  10/104 (9.62%)  9/186 (4.84%)  15/171 (8.77%) 
Blood bilirubin increased  1  5/104 (4.81%)  4/110 (3.64%)  9/107 (8.41%)  3/104 (2.88%)  9/186 (4.84%)  8/171 (4.68%) 
Aspartate aminotransferase increased  1  5/104 (4.81%)  7/110 (6.36%)  2/107 (1.87%)  7/104 (6.73%)  14/186 (7.53%)  12/171 (7.02%) 
Creatinine increased  1  5/104 (4.81%)  6/110 (5.45%)  5/107 (4.67%)  8/104 (7.69%)  10/186 (5.38%)  8/171 (4.68%) 
Metabolism and nutrition disorders             
Anorexia  1  7/104 (6.73%)  7/110 (6.36%)  6/107 (5.61%)  7/104 (6.73%)  17/186 (9.14%)  9/171 (5.26%) 
Hypoalbuminemia  1  12/104 (11.54%)  14/110 (12.73%)  20/107 (18.69%)  15/104 (14.42%)  24/186 (12.90%)  18/171 (10.53%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  20/104 (19.23%)  23/110 (20.91%)  32/107 (29.91%)  18/104 (17.31%)  37/186 (19.89%)  27/171 (15.79%) 
Bone pain  1  10/104 (9.62%)  11/110 (10.00%)  14/107 (13.08%)  7/104 (6.73%)  15/186 (8.06%)  10/171 (5.85%) 
Myalgia  1  25/104 (24.04%)  32/110 (29.09%)  38/107 (35.51%)  25/104 (24.04%)  57/186 (30.65%)  26/171 (15.20%) 
Nervous system disorders             
Dysgeusia  1  3/104 (2.88%)  2/110 (1.82%)  5/107 (4.67%)  4/104 (3.85%)  10/186 (5.38%)  4/171 (2.34%) 
Dizziness  1  5/104 (4.81%)  1/110 (0.91%)  4/107 (3.74%)  6/104 (5.77%)  7/186 (3.76%)  8/171 (4.68%) 
Peripheral sensory neuropathy  1  4/104 (3.85%)  4/110 (3.64%)  6/107 (5.61%)  13/104 (12.50%)  10/186 (5.38%)  7/171 (4.09%) 
Headache  1  28/104 (26.92%)  24/110 (21.82%)  22/107 (20.56%)  21/104 (20.19%)  42/186 (22.58%)  36/171 (21.05%) 
Psychiatric disorders             
Insomnia  1  3/104 (2.88%)  2/110 (1.82%)  5/107 (4.67%)  6/104 (5.77%)  9/186 (4.84%)  9/171 (5.26%) 
Anxiety  1  2/104 (1.92%)  4/110 (3.64%)  6/107 (5.61%)  5/104 (4.81%)  8/186 (4.30%)  2/171 (1.17%) 
Depression  1  3/104 (2.88%)  3/110 (2.73%)  2/107 (1.87%)  6/104 (5.77%)  10/186 (5.38%)  4/171 (2.34%) 
Skin and subcutaneous tissue disorders             
Hyperhidrosis  1  4/104 (3.85%)  4/110 (3.64%)  4/107 (3.74%)  6/104 (5.77%)  11/186 (5.91%)  7/171 (4.09%) 
Pruritus  1  8/104 (7.69%)  10/110 (9.09%)  15/107 (14.02%)  5/104 (4.81%)  17/186 (9.14%)  5/171 (2.92%) 
Rash maculo-papular  1  27/104 (25.96%)  22/110 (20.00%)  33/107 (30.84%)  13/104 (12.50%)  31/186 (16.67%)  17/171 (9.94%) 
Skin and subcutaneous tissue disorders -  1  15/104 (14.42%)  16/110 (14.55%)  11/107 (10.28%)  14/104 (13.46%)  22/186 (11.83%)  6/171 (3.51%) 
Vascular disorders             
Hot flashes  1  3/104 (2.88%)  1/110 (0.91%)  6/107 (5.61%)  3/104 (2.88%)  10/186 (5.38%)  3/171 (1.75%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 2.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: ECOG Statistical Office
Phone: 617-632-3012
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01989572     History of Changes
Obsolete Identifiers: NCT00005034
Other Study ID Numbers: NCI-2013-02101
NCI-2013-02101 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CALGB 500101
U10CA021115 ( U.S. NIH Grant/Contract )
ECOG-4697
CDR0000067568
SWOG-E4697
9546
E4697 ( Other Identifier: Eastern Cooperative Oncology Group )
E4697 ( Other Identifier: CTEP )
First Submitted: November 18, 2013
First Posted: November 21, 2013
Results First Submitted: July 22, 2014
Results First Posted: August 12, 2014
Last Update Posted: June 11, 2019