Bevacizumab With or Without Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00026221
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Melanoma
  • Stage IV Skin Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Recombinant Interferon Alfa — BIOLOGICAL
    Given SC
  • Bevacizumab — BIOLOGICAL
    Given IV

Study Details

This randomized phase II trial is studying giving bevacizumab together with interferon alpha to see how well it works compared to giving bevacizumab alone in treating patients with metastatic malignant melanoma. 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 alpha may interfere with the growth of the cancer cells and slow the growth of the tumor. Combining bevacizumab with interferon alpha may kill more tumor cells.

Key Dates

First listed
Jan 27, 2003
Start date
Nov 30, 2001
Status verified
Feb 2016
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (monoclonal antibody and biological therapy)
    Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.
  • Experimental: Arm II (monoclonal antibody)
    Patients receive bevacizumab as in arm I.
  • Experimental: Arm III (monoclonal antibody and biological therapy)
    Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.

Primary Outcome Measure

Objective Response Rate [ Time Frame: Up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of CincinnatiCincinnatiOhio45267-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-

Find similar trials in Cincinnati, OH

By research site
University of Cincinnati· Cincinnati, OHOhio State University Comprehensive Cancer Center· Columbus, OH

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