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| Sponsor: | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00026221 |
Purpose
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Interferon alfa may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alfa may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying giving bevacizumab together with interferon alfa to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: bevacizumab Biological: recombinant interferon alfa |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase 2 Study Of Bevacizumab And Interferon-Alpha-2b In Metastatic Malignant Melanoma |
| Estimated Enrollment: | 65 |
| Study Start Date: | December 2001 |
| Estimated Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-α) subcutaneously (SC) on days 1-14.
|
Biological: bevacizumab
Given IV
Biological: recombinant interferon alfa
Given subcutaneously
|
|
Arm II: Experimental
Patients receive bevacizumab as in arm I.
|
Biological: bevacizumab
Given IV
|
|
Arm III: Experimental
Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-α SC on days 1, 3, 5, 8, 10, and 12.
|
Biological: bevacizumab
Given IV
Biological: recombinant interferon alfa
Given subcutaneously
|
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
In all arms, treatment repeats every 14 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients undergo restaging at the completion of course 12. Patients with stable disease or a clinical response may continue treatment according to their assigned treatment arm for up to 1 year. Patients with stable disease after 1 year of treatment with bevacizumab and IFN-α (arms I and III) may continue to receive bevacizumab alone (as in arm II) in the absence of disease progression.
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study within 6-10 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed cutaneous malignant melanoma
Must meet one of the following criteria:
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No history of thrombosis (e.g., deep vein thrombosis), unless the following criteria are met:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
No prior cytokine therapy for metastatic disease (e.g., high-dose interleukin-2 [IL-2])
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210-1240 | |
| Contact: Ohio State University Cancer Clinical Trial Matching Service 866-627-7616 osu@emergingmed.com | |
| Study Chair: | William E. Carson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Responsible Party: | Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center ( Miguel A. Villalona-Calero ) |
| Study ID Numbers: | CDR0000069010, OSU-01H0185, NCI-2669 |
| Study First Received: | November 9, 2001 |
| Last Updated: | April 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00026221 History of Changes |
| Health Authority: | Unspecified |
|
stage IV melanoma recurrent melanoma |
|
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 Bevacizumab 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 |