|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
|---|---|
|
Experimental: Arm I
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
|
|
Experimental: Arm II
Patients receive bevacizumab as in arm I.
|
Biological: bevacizumab
Given IV
|
|
Experimental: Arm III
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 | |
| Columbus, Ohio, United States, 43210-1240 | |
| Study Chair: | William E. Carson, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
| Responsible Party: | Miguel A. Villalona-Calero, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00026221 History of Changes |
| Other Study ID Numbers: | CDR0000069010, OSU-01H0185, NCI-2669 |
| Study First Received: | November 9, 2001 |
| Last Updated: | February 6, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV melanoma recurrent 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 Interferons Bevacizumab |
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 |