Bevacizumab and Sorafenib in Treating Patients With Unresectable Stage III or Stage IV Malignant Melanoma

Part of paid clinical trials in San Antonio, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00387751
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Melanoma
  • Stage III Skin Melanoma
  • Stage IV Skin Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacological Study — OTHER
    Correlative studies
  • Sorafenib Tosylate — DRUG
    Given orally

Study Details

This phase II trial is studying how well giving bevacizumab together with sorafenib works in treating patients with unresectable stage III or stage IV malignant melanoma. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of melanoma by blocking blood flow to the tumor. Giving bevacizumab together with sorafenib may kill more tumor cells.

Key Dates

First listed
Oct 13, 2006
Start date
Aug 31, 2006
Status verified
Oct 2017
Primary completion
Sep 30, 2009
Completion
Jan 31, 2010

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive oral sorafenib tosylate on days 1-5, 8-12, 15-19, and 22-26 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.

Primary Outcome Measure

Response [ Time Frame: 4 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cancer Therapy and Research Center at The UT Health Science Center at San AntonioSan AntonioTexas78229-

Find similar trials in San Antonio, TX

By research site
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio· San Antonio, TX

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