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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B NCIC Clinical Trials Group Children's Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003641 |
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 |
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Melanoma (Skin) |
Biological: recombinant interferon alfa Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
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Arm I: No Intervention
Patients undergo observation for 4 weeks.
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Procedure: observation
Patients undergo observation for 4 weeks.
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Arm II: Experimental
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.
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Biological: recombinant interferon alfa
Given IV
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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.
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.
PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.
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:
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 |
Responsible Party: | ECOG Group Chair's Office ( Robert L. Comis ) |
Study ID Numbers: | CDR0000066727, ECOG-1697, SWOG-E1697, CALGB-500103, CAN-NCIC-ME10, COG-E1697 |
Study First Received: | November 1, 1999 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00003641 History of Changes |
Health Authority: | Unspecified |
stage II melanoma stage III melanoma |
Interferon-alpha Anti-Infective Agents Interferon Type I, Recombinant Immunologic Factors Interferons Angiogenesis Inhibitors Antiviral Agents Melanoma |
Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Nevus Interferon Alfa-2a Interferon Alfa-2b |
Interferon-alpha Anti-Infective Agents Interferon Type I, Recombinant Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Neoplasms, Nerve Tissue Interferons Angiogenesis Inhibitors Antiviral Agents |
Pharmacologic Actions Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Growth Inhibitors Angiogenesis Modulating Agents Interferon Alfa-2a |