Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaccine Therapy in Patients With Stage II, III, or IV Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00112957
Recruitment Status : Completed
First Posted : June 3, 2005
Results First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Collaborator:
Roswell Park Cancer Institute
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Interventions Biological: rV-NY-ESO-1 vaccine
Biological: rF-NY-ESO-1 vaccine
Enrollment 23
Recruitment Details  
Pre-assignment Details  
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Period Title: Overall Study
Started 23
Completed [1] 4
Not Completed 19
Reason Not Completed
Progressive disease             18
Physician Decision             1
[1]
Completed through the 12-month follow-up
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Baseline Participants 23
Hide Baseline Analysis Population Description
The Safety Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants
55
(37 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Female
23
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
23
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
23
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants
23
Karnofsky Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants
70
1
   4.3%
80
3
  13.0%
90
3
  13.0%
100
16
  69.6%
[1]
Measure Description: Functional impairment is as follows: 100=normal, no complaints; 90=able to carry on normal activities with minor signs/symptoms of disease; 80=normal activity with effort; 70=care for self, unable to carry on normal activity or to do active work; 60=requires occasional assistance, but able to care for most needs; 50=requires considerable assistance & frequent medical care; 40=disabled, requires special care and assistance; 30=severly disabled, hospitalization indicated though death nonimminent; 20=very sick, hospitalization necessary, active supportive treatment necessary; 10=moribund; 0=dead
Body mass index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 23 participants
29.5  (4.7)
1.Primary Outcome
Title Percentage of Patients in Remission at 1 Year
Hide Description Time to failure (TTF) was evaluated as the crude proportion of patients in remission at 1 year, calculated as: 100 x (number of patients in remission at 1 year)/(number of patients with known status at 1 year). The Kaplan-Meier cumulative estimate of the proportion of patients in remission at 1 year was also calculated.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Crude rate Number Analyzed 21 participants
38.1
(18.1 to 61.6)
Kaplan-Meier cumulative rate Number Analyzed 21 participants
38.8
(18.8 to 58.5)
2.Secondary Outcome
Title Mean Time to Failure Among Patients Who Progressed On Study
Hide Description TTF was calculated as the number of days from the first dose until the patient discontinued due to progressive disease. Patients who completed the study or discontinued for other reasons were considered censored at the day of their last study visit, including the follow-up visits after Day 197. Progression was defined using the Response Evaluation Criteria In Solid Tumors (RECIST [version 1.0]) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame Up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. TTF was calculated for the subset of patients who had disease progression at any time.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: days
253.1  (160.4)
3.Secondary Outcome
Title Number of Patients With Best Overall Tumor Response
Hide Description Tumor responses were evaluated using computed tomography and were categorized according to RECIST (version 1.0) at Screening, on Days 85 and 197 and every 2 months thereafter for at least 12 months. Per RECIST, target lesions are categorized as follows: Complete Response (CR): Disappearance of all target lesions (no evaluable disease); Partial Response (PR): ≥ 30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD): ≥ 20% increase in the sum of the longest diameter of target lesions; Stable Disease (SD): small changes that do not meet above criteria.
Time Frame Up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Response at Day 85 Stable Disease
3
  13.6%
Progressive Disease
0
   0.0%
No Evaluable Disease
15
  68.2%
Missing/Not Done
4
  18.2%
Response at Day 197 Stable Disease
3
  13.6%
Progressive Disease
1
   4.5%
No Evaluable Disease
11
  50.0%
Missing/Not Done
7
  31.8%
Response at 12-Month Follow-up Stable Disease
0
   0.0%
Progressive Disease
0
   0.0%
No Evaluable Disease
4
  18.2%
Missing/Not Done
18
  81.8%
Response at End of Study Stable Disease
3
  13.6%
Progressive Disease
4
  18.2%
No Evaluable Disease
0
   0.0%
Missing/Not Done
15
  68.2%
4.Secondary Outcome
Title Mean Absolute Cancer Antigen-125 Values Over Time on Study
Hide Description Blood samples were collected to measure serum levels of tumor marker cancer antigen (CA)-125 at Screening and on Days 1, 29, 57, 85, 113, 141, 169, and 197 and every 2 months for at least 12 months following Day 197.
Time Frame Up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: U/mL
CA-125 at Baseline Number Analyzed 22 participants
17.9  (15.4)
CA-125 at Day 29 Number Analyzed 22 participants
27.5  (40.7)
CA-125 at Day 57 Number Analyzed 21 participants
74.8  (203.7)
CA-125 at Day 85 Number Analyzed 18 participants
12.8  (9.6)
CA-125 at Day 113 Number Analyzed 18 participants
20.4  (33.6)
CA-125 at Day 141 Number Analyzed 16 participants
11.8  (7.2)
CA-125 at Day 169 Number Analyzed 16 participants
14.1  (9.3)
CA-125 at Day 197 Number Analyzed 15 participants
16.0  (13.4)
Follow-up at Month 2 Number Analyzed 13 participants
80.7  (205.9)
Follow-up at Month 4 Number Analyzed 9 participants
16.0  (14.6)
Follow-up at Month 6 Number Analyzed 7 participants
80.4  (187.2)
Follow-up at Month 8 Number Analyzed 6 participants
10.6  (3.5)
Follow-up at Month 10 Number Analyzed 6 participants
59.5  (120.5)
Follow-up at Month 12 Number Analyzed 4 participants
16.8  (12.6)
5.Secondary Outcome
Title Number of Patients With NY-ESO-1 and LAGE-1-specific Immunity
Hide Description Specific antibody response to the NY-ESO-1 and LAGE-1 antigen was measured by enzyme-linked immunosorbent assay (ELISA) at Screening, Days 29, 57, 85, 113, 141, 169, 197, Month 6, and Month 12.
Time Frame Up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Screening: NY-ESO-1 Positive Number Analyzed 22 participants
3
  13.6%
Screening: LAGE-1 Positive Number Analyzed 22 participants
2
   9.1%
Day 29: NY-ESO-1 Positive Number Analyzed 22 participants
7
  31.8%
Day 29: LAGE-1 Positive Number Analyzed 22 participants
5
  22.7%
Day 57: NY-ESO-1 Positive Number Analyzed 21 participants
6
  28.6%
Day 57: LAGE-1 Positive Number Analyzed 21 participants
4
  19.0%
Day 85: NY-ESO-1 Positive Number Analyzed 18 participants
5
  27.8%
Day 85: LAGE-1 Positive Number Analyzed 18 participants
4
  22.2%
Day 113: NY-ESO-1 Positive Number Analyzed 18 participants
6
  33.3%
Day 113: LAGE-1 Positive Number Analyzed 18 participants
3
  16.7%
Day 141: NY-ESO-1 Positive Number Analyzed 16 participants
5
  31.3%
Day 141: LAGE-1 Positive Number Analyzed 16 participants
3
  18.8%
Day 169: NY-ESO-1 Positive Number Analyzed 16 participants
5
  31.3%
Day 169: LAGE-1 Positive Number Analyzed 16 participants
3
  18.8%
Day 197: NY-ESO-1 Positive Number Analyzed 15 participants
5
  33.3%
Day 197: LAGE-1 Positive Number Analyzed 15 participants
3
  20.0%
Month 6: NY-ESO-1 Positive Number Analyzed 8 participants
4
  50.0%
Month 6: LAGE-1 Positive Number Analyzed 8 participants
0
   0.0%
Month 12: NY-ESO-1 Positive Number Analyzed 4 participants
1
  25.0%
Month 12: LAGE-1 Positive Number Analyzed 4 participants
1
  25.0%
6.Secondary Outcome
Title Number of Patients With Release of Interferon-Gamma by T Cells in Response to Cancer Antigens
Hide Description Intracellular cytokine staining assays were performed at Screening, Days 85 and 197, Month 6, and Month 12 to evaluate the release of interferon-gamma by CD4 and CD8 T cells following study injections.
Time Frame Up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Screening: CD4 Number Analyzed 22 participants
Positive
10
  45.5%
Negative
12
  54.5%
Screening: CD8 Number Analyzed 22 participants
Positive
2
   9.1%
Negative
20
  90.9%
Day 85: CD4 Number Analyzed 18 participants
Positive
13
  72.2%
Negative
5
  27.8%
Day 85: CD8 Number Analyzed 18 participants
Positive
6
  33.3%
Negative
12
  66.7%
Day 197: CD4 Number Analyzed 15 participants
Positive
12
  80.0%
Negative
3
  20.0%
Day 197: CD8 Number Analyzed 14 participants
Positive
5
  35.7%
Negative
9
  64.3%
Month 6: CD4 Number Analyzed 8 participants
Positive
6
  75.0%
Negative
2
  25.0%
Month 6: CD8 Number Analyzed 8 participants
Positive
3
  37.5%
Negative
5
  62.5%
Month 12: CD4 Number Analyzed 4 participants
Positive
3
  75.0%
Negative
1
  25.0%
Month 12: CD8 Number Analyzed 4 participants
Positive
1
  25.0%
Negative
3
  75.0%
7.Secondary Outcome
Title Number of Patients With Detectable T-cell Responses Following Vaccination
Hide Description NY-ESO-1-specific CD8+ T cells (human leukocyte antigen [HLA]-A2 patients only) and NY-ESO-1-specific CD4+ T cells (HLA-DP4 patients only) were measured by interferon-gamma enzyme-linked immunosorbent spot (ELISPOT) assay. The response to the ELISPOT assay was considered to be positive if the number of spots in the peptide-exposed well was 2-fold or more higher than the number of spots in the unstimulated well, and if there was a minimum of 10 (after subtraction of background spots) peptide-specific spots/25,000 T-cells, or less if T-cell clones were used.
Time Frame Up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
Detectable CD4+ T-cell response
20
  90.9%
Detectable CD8+ T-cell response
10
  45.5%
8.Secondary Outcome
Title Number of Patients With Delayed-Type Hypersensitivity Reactions Following Vaccination
Hide Description NY-ESO-1 antigen-specific delayed-type hypersensitivity (DTH) was measured by skin test at Screening and on Days 113 and 197. All patients were tested for the NY-ESO-1 protein, with additional DTH testing as follows: patients who were HLA-A2+ had NY-ESO-1b testing, patients who were HLA-DP4+ had NY-ESO-DP4 testing, and patients who were both HLA-A2+ and HLA-DP4+ had NY-ESO-1b and NY-ESO-DP4 testing.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1 and met the entry criterion of having epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. One patient with breast cancer was treated in the protocol under compassionate use and is excluded from the Full Analysis Set.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
NY-ESO-1 protein: Induration at Screening Number Analyzed 22 participants
1
   4.5%
NY-ESO-1 protein: Redness at Screening Number Analyzed 22 participants
5
  22.7%
NY-ESO-1 protein: Induration at Day 113 Number Analyzed 18 participants
1
   5.6%
NY-ESO-1 protein: Redness at Day 113 Number Analyzed 18 participants
4
  22.2%
NY-ESO-1 protein: Induration at Day 197 Number Analyzed 15 participants
0
   0.0%
NY-ESO-1 protein: Redness at Day 197 Number Analyzed 15 participants
1
   6.7%
NY-ESO-1b: Induration at Screening Number Analyzed 22 participants
1
   4.5%
NY-ESO-1b: Redness at Screening Number Analyzed 22 participants
1
   4.5%
NY-ESO-1b: Induration at Day 113 Number Analyzed 18 participants
0
   0.0%
NY-ESO-1b: Redness at Day 113 Number Analyzed 18 participants
0
   0.0%
NY-ESO-1b: Induration at Day 197 Number Analyzed 15 participants
0
   0.0%
NY-ESO-1b: Redness at Day 197 Number Analyzed 15 participants
0
   0.0%
NY-ESO-DP4: Induration at Screening Number Analyzed 22 participants
0
   0.0%
NY-ESO-DP4: Redness at Screening Number Analyzed 22 participants
2
   9.1%
NY-ESO-DP4: Induration at Day 113 Number Analyzed 18 participants
0
   0.0%
NY-ESO-DP4: Redness at Day 113 Number Analyzed 18 participants
0
   0.0%
NY-ESO-DP4: Induration at Day 197 Number Analyzed 15 participants
0
   0.0%
NY-ESO-DP4: Redness at Day 197 Number Analyzed 15 participants
0
   0.0%
9.Secondary Outcome
Title Number of Patients With Treatment-emergent Adverse Events
Hide Description Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period.
Time Frame Continuously for up to 20 months
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set includes all patients who received at least 1 injection with rV-NY-ESO-1 or rF-NY-ESO-1.
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description:
Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
Overall Number of Participants Analyzed 23
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
23
 100.0%
Maximum grade 1 TEAE
3
  13.0%
Maximum grade 2 TEAE
15
  65.2%
Maximum grade 3 TEAE
3
  13.0%
Maximum grade 4 TEAE
2
   8.7%
Treatment-related TEAE
9
  39.1%
Serious TEAE
4
  17.4%
TEAE Leading to Treatment Discontinuation
2
   8.7%
Time Frame All adverse events (AEs) occurring between the signing of informed consent and the off-study date were documented, regardless of the causal relationship to study drug. AEs occurring after the first dose of study drug were considered treatment emergent (i.e., TEAEs). The AE reporting period for this study was up to 20 months.
Adverse Event Reporting Description AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a “possible”, “probable”, or “definite” relationship to study drug; preferred terms were counted only once per patient at the maximum reported grade.
 
Arm/Group Title rV- and rF-NY-ESO-1
Hide Arm/Group Description Patients received a single intradermal injection of rV-NY-ESO-1 (3.1 × 10^7 PFU) on Day 1, followed by subcutaneous injections of rF-NY-ESO-1 (7.41 × 10^7 PFU) on Days 29, 57, 85, 113, 141, and 169 or until observation of treatment-related ≥ grade 3 toxicity or disease progression.
All-Cause Mortality
rV- and rF-NY-ESO-1
Affected / at Risk (%)
Total   0/23 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
rV- and rF-NY-ESO-1
Affected / at Risk (%)
Total   4/23 (17.39%) 
Gastrointestinal disorders   
Small intestinal obstruction  1  1/23 (4.35%) 
Abdominal pain  1  1/23 (4.35%) 
Infections and infestations   
Urinary tract infection  1  1/23 (4.35%) 
Pneumonia  1  1/23 (4.35%) 
Septic shock  1  1/23 (4.35%) 
Musculoskeletal and connective tissue disorders   
Pathological fracture  1  1/23 (4.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung neoplasm  1  1/23 (4.35%) 
Psychiatric disorders   
Mental status changes  1  1/23 (4.35%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/23 (4.35%) 
Respiratory failure  1  1/23 (4.35%) 
1
Term from vocabulary, MedDRA (9.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
rV- and rF-NY-ESO-1
Affected / at Risk (%)
Total   23/23 (100.00%) 
Gastrointestinal disorders   
Abdominal pain  1  4/23 (17.39%) 
Abdominal pain upper  1  4/23 (17.39%) 
Nausea  1  4/23 (17.39%) 
Vomiting  1  3/23 (13.04%) 
Abdominal distension  1  2/23 (8.70%) 
Diarrhoea  1  2/23 (8.70%) 
General disorders   
Chest pain  1  3/23 (13.04%) 
Pyrexia  1  3/23 (13.04%) 
Fatigue  1  2/23 (8.70%) 
Injection site pruritus  1  2/23 (8.70%) 
Injection site reaction  1  2/23 (8.70%) 
Injection site scab  1  2/23 (8.70%) 
Oedema peripheral  1  2/23 (8.70%) 
Pain  1  2/23 (8.70%) 
Infections and infestations   
Nasopharyngitis  1  4/23 (17.39%) 
Urinary tract infection  1  2/23 (8.70%) 
Bronchitis  1  2/23 (8.70%) 
Sinusitis  1  2/23 (8.70%) 
Investigations   
Skin test positive  1  20/23 (86.96%) 
Blood creatinine increased  1  2/23 (8.70%) 
Blood glucose increased  1  2/23 (8.70%) 
Blood urea increased  1  2/23 (8.70%) 
Metabolism and nutrition disorders   
Hyperkalaemia  1  2/23 (8.70%) 
Hyponatraemia  1  2/23 (8.70%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  4/23 (17.39%) 
Arthralgia  1  2/23 (8.70%) 
Muscle spasms  1  2/23 (8.70%) 
Pain in extremity  1  2/23 (8.70%) 
Nervous system disorders   
Neuropathy peripheral  1  3/23 (13.04%) 
Dizziness  1  2/23 (8.70%) 
Headache  1  2/23 (8.70%) 
Psychiatric disorders   
Insomnia  1  3/23 (13.04%) 
Renal and urinary disorders   
Pollakiuria  1  2/23 (8.70%) 
Reproductive system and breast disorders   
Breast tenderness  1  2/23 (8.70%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/23 (17.39%) 
Dyspnoea  1  3/23 (13.04%) 
Nasal congestion  1  3/23 (13.04%) 
Wheezing  1  2/23 (8.70%) 
Skin and subcutaneous tissue disorders   
Rash  1  3/23 (13.04%) 
1
Term from vocabulary, MedDRA (9.0)
Indicates events were collected by systematic assessment
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: Mary Macri, Director, Clinical Trials Management
Organization: Ludwig Institute for Cancer Research
Phone: (212) 450-1546
EMail: mmacri@licr.org
Layout table for additonal information
Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT00112957     History of Changes
Other Study ID Numbers: LUD 2002-012
RPCI-I-13303
CDR0000424461
First Submitted: June 2, 2005
First Posted: June 3, 2005
Results First Submitted: February 13, 2018
Results First Posted: March 19, 2018
Last Update Posted: March 19, 2018