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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B NCIC Clinical Trials Group Children's Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00003641 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: recombinant interferon alfa Other: clinical observation |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage TN ,TN, TN, and T, N (Microscopic) Melanoma |
| Estimated Enrollment: | 1420 |
| Study Start Date: | December 1998 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Arm I
Patients undergo observation for 4 weeks.
|
Other: clinical observation
Patients undergo observation for 4 weeks.
|
|
Experimental: Arm II
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: recombinant interferon alfa
Given IV
|
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified by pathologic lymph node status (known vs unknown by sentinel lymph node procedure vs by elective lymph node dissection vs by no lymphadenectomy), Breslow depth (< 1.0 mm [lymph node positive patients only] 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 [N_1a, N_2a microscopic] vs lymph node negative [N_0]). Patients are randomized into one of two treatment arms.
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.
PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary melanoma of cutaneous origin
Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)
Stage III (T4 N0 M0)
Stage III (T1-4 N1)
Patients must meet at least 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
No other concurrent or prior malignancies within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 533 Study Locations| Study Chair: | Sanjiv S. Agarwala, MD | St. Luke's Cancer Network at St. Luke's Hospital |
| Investigator: | 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 | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
| 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 |
More Information
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00003641 History of Changes |
| Other Study ID Numbers: | CDR0000066727, ECOG-1697, SWOG-E1697, CALGB-500103, CAN-NCIC-ME10, COG-E1697 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 13, 2011 |
| Health Authority: | United States: Federal Government |
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stage II melanoma stage III melanoma |
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-alpha Interferon Alfa-2a Interferon Alfa-2b Interferons |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |