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Trial record 14 of 510 for:    melanoma phase III

S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma

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: NCT00006237
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : September 19, 2012
Last Update Posted : March 25, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Cancer and Leukemia Group B
Children's Oncology Group
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma (Skin)
Interventions Biological: interleukin-2
Biological: filgrastim
Biological: interferon alfa
Drug: cisplatin
Drug: dacarbazine
Drug: vinblastine
Enrollment 432
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interferon Biochemotherapy
Hide Arm/Group Description interferon alfa IV cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
Period Title: Overall Study
Started 212 220
Eligible 203 200
Eligible and Treated 203 199
Completed 87 159
Not Completed 125 61
Reason Not Completed
Adverse Event             39             29
Death             1             0
Refusal unrelated to adverse effects             8             4
Progression/relapse             54             2
Not eligible             9             20
Withdrawal by Subject             0             1
Not protocol specified             14             5
Arm/Group Title Interferon Biochemotherapy Total
Hide Arm/Group Description interferon alfa cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim Total of all reporting groups
Overall Number of Baseline Participants 203 199 402
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 203 participants 199 participants 402 participants
47
(12 to 73)
46
(10 to 74)
47
(10 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 203 participants 199 participants 402 participants
Female
62
  30.5%
58
  29.1%
120
  29.9%
Male
141
  69.5%
141
  70.9%
282
  70.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 203 participants 199 participants 402 participants
203 199 402
1.Primary Outcome
Title 5-year Overall Survival
Hide Description Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
Time Frame Every three months for a year, every six months for years 2-5, annual for years 5-10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Biochemotherapy
Hide Arm/Group Description:
interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
Overall Number of Participants Analyzed 203 199
Measure Type: Number
Unit of Measure: Percent of population
56 56
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon, Biochemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Primary Outcome
Title 5-year Relapse-Free Survival
Hide Description Measured from date of registration to date of first observation of progressive disease or death due to any cause.
Time Frame Every three months for the first year, every 6 months for years 2-5, annually for years 6-10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Biochemotherapy
Hide Arm/Group Description:
interferon alfa
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
Overall Number of Participants Analyzed 203 199
Measure Type: Number
Unit of Measure: Percentage of population
47 38
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interferon, Biochemotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Toxicity
Hide Description Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Time Frame While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who started therapy
Arm/Group Title Interferon Biochemotherapy
Hide Arm/Group Description:
Interferon
Biochemotherapy
Overall Number of Participants Analyzed 193 185
Measure Type: Number
Unit of Measure: Participants
Abdominal pain/cramping 1 1
Acidosis 0 1
Acute vascular leak syndrome 0 1
Alkaline phosphatase increase 0 3
Allergic reaction 1 0
Anal incontinence 0 1
Anemia 0 8
Anorexia 1 9
Anxiety/agitation 4 5
Apnea 1 0
Arrhythmia, NOS 2 0
Arthralgia 4 3
Bilirubin increase 0 1
Bone pain 0 4
CPK increase 0 1
Cardiovascular-other 1 0
Catheter related infection 0 2
Cerebrovascular ischemia 1 0
Colitis 0 2
Confusion 2 3
Constipation/bowel obstruction 0 4
Cranial neuropathy 1 0
Creatinine increase 0 4
Dehydration 1 7
Delusions 0 1
Depression 14 4
Diarrhea without colostomy 2 6
Dizziness/light headedness 2 1
Dizziness/vertigo, NOS 0 1
Double vision 0 1
Dyspnea 1 2
Eryth/rash/eruption/desq, NOS 1 3
Esophagitis/dysphagia 0 2
Eye-other 1 0
Fatigue/malaise/lethargy 38 22
Febrile neutropenia 1 9
Fever without neutropenia 1 5
Fever, NOS 0 1
Hallucinations 1 1
Headache 9 5
Hemorrhage w/ 3-4 thrombocyt 0 1
Hyperglycemia 2 3
Hyperkalemia 0 1
Hypermagnesemia 1 1
Hypertension 0 1
Hypertriglyceridemia 1 0
Hypocalcemia 0 18
Hypokalemia 1 7
Hypomagnesemia 0 5
Hyponatremia 0 6
Hypophosphatemia 0 4
Hypotension 0 16
Hypoxia 0 1
Infection w/o 3-4 neutropenia 0 3
Infection with 3-4 neutropenia 0 9
Infection, unk ANC 1 2
Insomnia 1 1
Leukopenia 12 38
Lipase increase 1 2
Local injection site reaction 1 0
Lymphopenia 0 2
Mood/consciousness change, NOS 0 1
Muscle weakness (not neuro) 0 1
Myalgia 7 4
Nausea 10 51
Neutropenia/granulocytopenia 25 61
PRBC transfusion 0 3
Pancreatitis 0 1
Personality/behavioral change 1 0
Petechiae/purpura 0 1
Platelet transfusion 0 5
Pruritus 1 3
Rash/desquamation 4 10
Renal failure 0 1
Reportable adverse event, NOS 1 1
Respiratory infect w/ neutrop 0 2
Rigors/chills 2 1
SGOT (AST) increase 18 7
SGPT (ALT) increase 32 8
Seizures 0 2
Sensory neuropathy 0 2
Stomatitis/pharyngitis 0 1
Surgery-wound infection 3 0
Syncope 2 0
Thrombocytopenia 1 50
Thrombosis/embolism 1 1
Typhlitis 0 1
Vertigo 1 0
Vomiting 9 37
Weakness (motor neuropathy) 1 2
Weight loss 3 0
Time Frame While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Adverse Event Reporting Description Regular investigator assessments are reported after each cycle of protocol treatment
 
Arm/Group Title Interferon Biochemotherapy
Hide Arm/Group Description interferon alfa cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
All-Cause Mortality
Interferon Biochemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Interferon Biochemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   2/193 (1.04%)   4/185 (2.16%) 
Blood and lymphatic system disorders     
Platelet transfusion  1  0/193 (0.00%)  1/185 (0.54%) 
Gastrointestinal disorders     
Colitis  1  0/193 (0.00%)  1/185 (0.54%) 
General disorders     
Reportable adverse event, NOS  1  1/193 (0.52%)  0/185 (0.00%) 
Infections and infestations     
Respiratory infect w/ neutrop  1  0/193 (0.00%)  1/185 (0.54%) 
Nervous system disorders     
Cerebrovascular ischemia  1  1/193 (0.52%)  0/185 (0.00%) 
Psychiatric disorders     
Depression  1  0/193 (0.00%)  1/185 (0.54%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Interferon Biochemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   132/193 (68.39%)   144/185 (77.84%) 
Blood and lymphatic system disorders     
Anemia  1  15/193 (7.77%)  27/185 (14.59%) 
Gastrointestinal disorders     
Diarrhea without colostomy  1  13/193 (6.74%)  0/185 (0.00%) 
Nausea  1  37/193 (19.17%)  67/185 (36.22%) 
Vomiting  1  23/193 (11.92%)  52/185 (28.11%) 
General disorders     
Fatigue/malaise/lethargy  1  79/193 (40.93%)  27/185 (14.59%) 
Fever without neutropenia  1  23/193 (11.92%)  24/185 (12.97%) 
Rigors/chills  1  27/193 (13.99%)  0/185 (0.00%) 
Investigations     
Alkaline phosphatase increase  1  0/193 (0.00%)  16/185 (8.65%) 
Creatinine increase  1  0/193 (0.00%)  13/185 (7.03%) 
Leukopenia  1  30/193 (15.54%)  42/185 (22.70%) 
Neutropenia/granulocytopenia  1  38/193 (19.69%)  65/185 (35.14%) 
SGOT (AST) increase  1  42/193 (21.76%)  20/185 (10.81%) 
SGPT (ALT) increase  1  53/193 (27.46%)  20/185 (10.81%) 
Thrombocytopenia  1  15/193 (7.77%)  58/185 (31.35%) 
Weight loss  1  12/193 (6.22%)  0/185 (0.00%) 
Metabolism and nutrition disorders     
Anorexia  1  0/193 (0.00%)  11/185 (5.95%) 
Hypocalcemia  1  0/193 (0.00%)  35/185 (18.92%) 
Hypomagnesemia  1  0/193 (0.00%)  18/185 (9.73%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  12/193 (6.22%)  0/185 (0.00%) 
Myalgia  1  23/193 (11.92%)  14/185 (7.57%) 
Nervous system disorders     
Headache  1  17/193 (8.81%)  0/185 (0.00%) 
Psychiatric disorders     
Anxiety/agitation  1  12/193 (6.22%)  10/185 (5.41%) 
Depression  1  31/193 (16.06%)  0/185 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  0/193 (0.00%)  11/185 (5.95%) 
Vascular disorders     
Hypotension  1  0/193 (0.00%)  22/185 (11.89%) 
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 NOT 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
Name/Title: SWOG Melanoma Statistician
Organization: SWOG statistical office
Phone: 206-667-4408
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00006237     History of Changes
Obsolete Identifiers: NCT00546416
Other Study ID Numbers: S0008
U10CA032102 ( U.S. NIH Grant/Contract )
S0008 ( Other Identifier: SWOG )
CALGB-500002 ( Other Identifier: CALGB )
ECOG-S0008 ( Other Identifier: ECOG )
COG-S0008 ( Other Identifier: COG )
First Submitted: September 11, 2000
First Posted: January 27, 2003
Results First Submitted: August 20, 2012
Results First Posted: September 19, 2012
Last Update Posted: March 25, 2015