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Trial record 5 of 519 for:    melanoma phase III

High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III 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: NCT00003641
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : May 4, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Southwest Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Children's Oncology Group
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Melanoma (Skin)
Interventions Biological: interferon alfa-2b
Other: observation
Enrollment 1150
Recruitment Details The study was activated on December 22, 1998, and closed to accrual on October 26, 2010 with final accrual of 1150 patients
Pre-assignment Details  
Arm/Group Title Observation Interferon Alfa-2b
Hide Arm/Group Description Patients undergo observation for 4 weeks.

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

interferon alfa-2b: Given IV

Period Title: Overall Study
Started 569 581
Treated 2 [1] 569
Toxicity Assessed 439 [2] 568
Completed 0 407
Not Completed 569 174
Reason Not Completed
Withdrawal by Subject             0             100
Adverse Event             0             38
Disease progression             0             2
Unknown/missing             0             22
Should not receive interferon therapy             2             0
Never started interferon             567             12
[1]
Patients on arm I should undergo observation, but 2 patients received interferon therapy
[2]
439 patients on arm I had their toxicity assessed even though they did not receive any treatment
Arm/Group Title Observation Interferon Alfa-2b Total
Hide Arm/Group Description Patients undergo observation for 4 weeks.

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

interferon alfa-2b: Given IV

Total of all reporting groups
Overall Number of Baseline Participants 569 581 1150
Hide Baseline Analysis Population Description
All randomized patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 569 participants 581 participants 1150 participants
52
(19 to 81)
52
(10 to 85)
52
(10 to 85)
Sex/Gender, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 569 participants 581 participants 1150 participants
Female 248 244 492
Male 320 336 656
Missing 1 1 2
[1]
Measure Description: 1 patient on arm I and 1 patient on arm II had missing information about sex
1.Primary Outcome
Title 5-year Relapse-free Survival Rate
Hide Description Relapse-free survival (RFS) was defined as time from randomization to disease relapse or death from any cause, whichever occurred first. Patients without disease relapse were censored at last disease assessment date known of free of relapse. Kaplan-Meier method was used to estimate 5-year RFS rate in the intent-to-treat (ITT) patients.
Time Frame assessed every 3 months for 2 years, every 6 months for 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients
Arm/Group Title Observation Interferon Alfa-2b
Hide Arm/Group Description:
Patients undergo observation for 4 weeks.

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

interferon alfa-2b: Given IV

Overall Number of Participants Analyzed 569 581
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.70
(0.66 to 0.74)
0.70
(0.66 to 0.74)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observation, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.964
Comments [Not Specified]
Method Log Rank
Comments stratified on the stratification factors used for randomization
2.Secondary Outcome
Title 5-year Overall Survival Rate
Hide Description Overall survival (OS) was defined as time from randomization to death from any cause. Patients still alive were censored at last known alive date. Kaplan-Meier method was used to estimate 5-year OS rate in the ITT patients.
Time Frame assessed every 3 months for 2 years, every 6 months for 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
all randomized patients
Arm/Group Title Observation Interferon Alfa-2b
Hide Arm/Group Description:
Patients undergo observation for 4 weeks.

Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

interferon alfa-2b: Given IV

Overall Number of Participants Analyzed 569 581
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
0.83
(0.79 to 0.86)
0.83
(0.80 to 0.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Observation, Interferon Alfa-2b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.558
Comments [Not Specified]
Method Log Rank
Comments Stratified on the stratification factors used for randomization
Time Frame Assessed at the end of treatment (4 weeks) and for 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first
Adverse Event Reporting Description Prior to diagnosis of relapse, any severe (Grade ≥ 3) long term toxicity that has not been previously reported was collected via the long-term follow up form, assessed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter until 15 years after randomization.These long term toxicities were included here as well.
 
Arm/Group Title Observation Interferon Alfa-2b
Hide Arm/Group Description Patients undergo observation for 4 weeks Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days
All-Cause Mortality
Observation Interferon Alfa-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Observation Interferon Alfa-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   20/439 (4.56%)   325/568 (57.22%) 
Blood and lymphatic system disorders     
Anemia  1  1/439 (0.23%)  0/568 (0.00%) 
Hematologic-other  1  0/439 (0.00%)  1/568 (0.18%) 
Cardiac disorders     
Supraventricular arrhythmias  1  0/439 (0.00%)  1/568 (0.18%) 
Cardiac-ischemia  1  0/439 (0.00%)  2/568 (0.35%) 
Cardiac-left ventric  1  0/439 (0.00%)  1/568 (0.18%) 
Myocarditis  1  0/439 (0.00%)  1/568 (0.18%) 
Ear and labyrinth disorders     
INNER EAR/HEARING  1  2/439 (0.46%)  0/568 (0.00%) 
Gastrointestinal disorders     
Constipation  1  0/439 (0.00%)  4/568 (0.70%) 
Nausea  1  0/439 (0.00%)  28/568 (4.93%) 
STOMATITIS  1  0/439 (0.00%)  1/568 (0.18%) 
Vomiting  1  0/439 (0.00%)  19/568 (3.35%) 
GI-other  1  0/439 (0.00%)  2/568 (0.35%) 
Abdominal pain  1  0/439 (0.00%)  2/568 (0.35%) 
General disorders     
Fatigue  1  0/439 (0.00%)  70/568 (12.32%) 
Fever  1  0/439 (0.00%)  4/568 (0.70%) 
Rigors/chills  1  0/439 (0.00%)  1/568 (0.18%) 
CONSTITUTIONAL  1  0/439 (0.00%)  1/568 (0.18%) 
Chest pain  1  0/439 (0.00%)  1/568 (0.18%) 
Pain-other  1  0/439 (0.00%)  1/568 (0.18%) 
Immune system disorders     
Allergic reaction  1  0/439 (0.00%)  1/568 (0.18%) 
Infections and infestations     
Catheter-related infection  1  0/439 (0.00%)  1/568 (0.18%) 
Infection w/ grade 3 or 4 neutropenia  1  0/439 (0.00%)  2/568 (0.35%) 
INFECTION W/ UNKNOWN ANC  1  0/439 (0.00%)  2/568 (0.35%) 
Infection w/o neutropenia  1  0/439 (0.00%)  2/568 (0.35%) 
INFECTION-OTHER  1  0/439 (0.00%)  2/568 (0.35%) 
Investigations     
Leukocytes decreased  1  0/439 (0.00%)  38/568 (6.69%) 
Neutrophils decreased  1  8/439 (1.82%)  130/568 (22.89%) 
Platelets decreased  1  0/439 (0.00%)  3/568 (0.53%) 
Alkaline phosphatase increased  1  2/439 (0.46%)  2/568 (0.35%) 
Blood bilirubin increased  1  1/439 (0.23%)  4/568 (0.70%) 
GGT increased  1  0/439 (0.00%)  2/568 (0.35%) 
Aspartate aminotransferase increased  1  1/439 (0.23%)  74/568 (13.03%) 
Alanine aminotransferase increased  1  0/439 (0.00%)  30/568 (5.28%) 
Creatinine increased  1  6/439 (1.37%)  13/568 (2.29%) 
Metabolism and nutrition disorders     
Anorexia  1  0/439 (0.00%)  11/568 (1.94%) 
Dehydration  1  0/439 (0.00%)  1/568 (0.18%) 
HYPERGLYCEMIA  1  0/439 (0.00%)  1/568 (0.18%) 
HYPERTRIGLYCERIDEMIA  1  0/439 (0.00%)  1/568 (0.18%) 
HYPOCALCEMIA  1  0/439 (0.00%)  1/568 (0.18%) 
HYPOKALEMIA  1  0/439 (0.00%)  1/568 (0.18%) 
HYPONATREMIA  1  0/439 (0.00%)  1/568 (0.18%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/439 (0.00%)  7/568 (1.23%) 
Bone pain  1  0/439 (0.00%)  2/568 (0.35%) 
Myalgia  1  0/439 (0.00%)  13/568 (2.29%) 
Nervous system disorders     
Vasovagal episode  1  0/439 (0.00%)  1/568 (0.18%) 
Ataxia  1  0/439 (0.00%)  1/568 (0.18%) 
Depressed level of consciousness  1  0/439 (0.00%)  3/568 (0.53%) 
Dizziness/lightheadedness  1  0/439 (0.00%)  3/568 (0.53%) 
Memory loss  1  0/439 (0.00%)  1/568 (0.18%) 
Neuropathy-cranial  1  0/439 (0.00%)  1/568 (0.18%) 
Neuropathy-motor  1  0/439 (0.00%)  3/568 (0.53%) 
Seizure  1  0/439 (0.00%)  1/568 (0.18%) 
Speech impairment  1  0/439 (0.00%)  2/568 (0.35%) 
Syncope  1  1/439 (0.23%)  3/568 (0.53%) 
VERTIGO  1  0/439 (0.00%)  1/568 (0.18%) 
Neurologic-other  1  0/439 (0.00%)  1/568 (0.18%) 
Headache  1  0/439 (0.00%)  42/568 (7.39%) 
Psychiatric disorders     
Confusion  1  0/439 (0.00%)  4/568 (0.70%) 
Insomnia  1  0/439 (0.00%)  5/568 (0.88%) 
Anxiety/agitation  1  0/439 (0.00%)  6/568 (1.06%) 
Depression  1  0/439 (0.00%)  11/568 (1.94%) 
Renal and urinary disorders     
Hematuria  1  0/439 (0.00%)  1/568 (0.18%) 
URINARY FREQUENCY/URGENCY  1  0/439 (0.00%)  1/568 (0.18%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea  1  0/439 (0.00%)  2/568 (0.35%) 
HYPOXIA  1  0/439 (0.00%)  1/568 (0.18%) 
PLEURAL EFFUSION  1  0/439 (0.00%)  1/568 (0.18%) 
Pneumonitis/pulmonary infiltrates  1  0/439 (0.00%)  1/568 (0.18%) 
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  0/439 (0.00%)  5/568 (0.88%) 
Vascular disorders     
Hypertension  1  2/439 (0.46%)  5/568 (0.88%) 
Hypotension  1  0/439 (0.00%)  1/568 (0.18%) 
Thrombosis/embolism  1  0/439 (0.00%)  1/568 (0.18%) 
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%
Observation Interferon Alfa-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   74/439 (16.86%)   558/568 (98.24%) 
Blood and lymphatic system disorders     
Anemia  1  12/439 (2.73%)  123/568 (21.65%) 
Gastrointestinal disorders     
Constipation  1  2/439 (0.46%)  106/568 (18.66%) 
Nausea  1  1/439 (0.23%)  340/568 (59.86%) 
Vomiting  1  0/439 (0.00%)  133/568 (23.42%) 
GI-other  1  0/439 (0.00%)  41/568 (7.22%) 
General disorders     
Fatigue  1  11/439 (2.51%)  454/568 (79.93%) 
Fever  1  0/439 (0.00%)  256/568 (45.07%) 
Rigors/chills  1  0/439 (0.00%)  342/568 (60.21%) 
Pain-other  1  17/439 (3.87%)  33/568 (5.81%) 
Investigations     
Leukocytes decreased  1  6/439 (1.37%)  321/568 (56.51%) 
Neutrophils decreased  1  4/439 (0.91%)  283/568 (49.82%) 
Platelets decreased  1  2/439 (0.46%)  200/568 (35.21%) 
Weight loss  1  0/439 (0.00%)  120/568 (21.13%) 
Alkaline phosphatase increased  1  2/439 (0.46%)  69/568 (12.15%) 
Blood bilirubin increased  1  2/439 (0.46%)  43/568 (7.57%) 
Aspartate aminotransferase increased  1  8/439 (1.82%)  373/568 (65.67%) 
Alanine aminotransferase increased  1  4/439 (0.91%)  80/568 (14.08%) 
Metabolism and nutrition disorders     
Anorexia  1  0/439 (0.00%)  283/568 (49.82%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  4/439 (0.91%)  137/568 (24.12%) 
Myalgia  1  3/439 (0.68%)  229/568 (40.32%) 
Nervous system disorders     
Taste disturbance  1  0/439 (0.00%)  176/568 (30.99%) 
Dizziness/lightheadedness  1  0/439 (0.00%)  95/568 (16.73%) 
Neuropathy-sensory  1  8/439 (1.82%)  41/568 (7.22%) 
Headache  1  8/439 (1.82%)  270/568 (47.54%) 
Psychiatric disorders     
Insomnia  1  3/439 (0.68%)  113/568 (19.89%) 
Anxiety/agitation  1  7/439 (1.59%)  91/568 (16.02%) 
Depression  1  4/439 (0.91%)  90/568 (15.85%) 
Skin and subcutaneous tissue disorders     
Sweating  1  0/439 (0.00%)  83/568 (14.61%) 
Alopecia  1  1/439 (0.23%)  30/568 (5.28%) 
Rash/desquamation  1  3/439 (0.68%)  64/568 (11.27%) 
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-ACRIN Statistical Office
Phone: 617-632-3012
Layout table for additonal information
Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ClinicalTrials.gov Identifier: NCT00003641     History of Changes
Other Study ID Numbers: E1697
E1697 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA023318 ( U.S. NIH Grant/Contract )
CDR0000066727 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: February 2, 2016
Results First Posted: May 4, 2016
Last Update Posted: March 13, 2019