High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma
|ClinicalTrials.gov Identifier: NCT00003641|
Recruitment Status : Terminated (The third interim analysis showed that there was no evidence of benefit from treatment with interferon.)
First Posted : January 27, 2003
Results First Posted : May 4, 2016
Last Update Posted : May 4, 2016
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.
PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: interferon alfa-2b Other: observation||Phase 3|
- Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma.
- Compare the effect of this treatment regimen on overall survival of these patients.
- Assess the toxicity of this treatment in these patients.
- Compare the effect of treatment on quality of life.
OUTLINE: This is a randomized study. Patients are stratified by pathologic lymph node status (known vs unknown),lymph node staging procedures(sentinel lymph node procedure vs. elective lymph node dissection vs. no lymphadenectomy), Breslow depth (<= 1.0 mm vs. 1.01-2.0 mm vs. 2.01-4.0 mm vs > 4.0 mm), ulceration of the primary lesion (yes vs. no vs. unknown), and disease stage (lymph node positive [N1, N2a] vs. lymph node negative [N0]). Patients are randomized into one of two treatment arms in a 1:1 ratio.
- Arm I (observation): Patients undergo observation for 4 weeks.
- Arm II (Interferon Alfa-2b): Patients receive high-dose interferon alfa-2b intravenously (IV) over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
Quality of life is assessed before treatment, at day 22, every 3 months for 2 years, and then every 6 months for 3 years.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter until 15 years after randomization.
PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage T2bN0, T3a-bN0, T4a-bN0, and T1-4, N1a,2a (Microscopic) Melanoma|
|Study Start Date :||December 1998|
|Actual Primary Completion Date :||January 2015|
|Estimated Study Completion Date :||October 2025|
Patients undergo observation for 4 weeks.
Patients undergo observation for 4 weeks.
Other Name: clinical observation
Experimental: Interferon Alfa-2b
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.
Biological: interferon alfa-2b
- 5-year Relapse-free Survival Rate [ Time Frame: assessed every 3 months for 2 years, every 6 months for 3 years ]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.
- 5-year Overall Survival Rate [ Time Frame: assessed every 3 months for 2 years, every 6 months for 3 years ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003641
Show 533 Study Locations
|Study Chair:||Sanjiv S. Agarwala, MD||St. Luke's Cancer Network at St. Luke's Hospital|
|Study Chair:||John M. Kirkwood, MD||UPMC Cancer Center at UPMC Presbyterian|
|Study Chair:||Lawrence E. Flaherty, MD||Barbara Ann Karmanos Cancer Institute|
|Study Chair:||William E. Carson, MD||Ohio State University Comprehensive Cancer Center|
|Study Chair:||Michael Smylie, MD, MB, ChB||Cross Cancer Institute at University of Alberta|
|Principal Investigator:||Alberto S. Pappo, MD||Texas Children's Cancer Center|