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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00397982
Phase
PHASE2
Status
Completed

Conditions

  • Recurrent Melanoma
  • Stage IIIB Skin Melanoma
  • Stage IIIC Skin Melanoma
  • Stage IV Skin Melanoma

Eligibility Criteria

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

Interventions

  • Bevacizumab — BIOLOGICAL
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Temsirolimus — DRUG
    Given IV
  • Therapeutic Conventional Surgery — PROCEDURE
    Undergo tumor resection

Study Details

This phase II trial is studying how well giving temsirolimus together with bevacizumab works in treating patients with stage III or stage IV malignant melanoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. 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. Bevacizumab may also stop the growth of malignant melanoma by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.

Key Dates

First listed
Nov 10, 2006
Start date
Jan 31, 2008
Status verified
May 2017
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

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

Arms

  • Experimental: Treatment (enzyme inhibitor, monoclonal antibody)
    Patients receive temsirolimus IV over 30 minutes on days 1 and 8 and bevacizumab IV over 30-90 minutes on day 8. Treatment repeats every 14 days for a maximum of 26 courses in the absence of disease progression or unacceptable toxicity. Patients undergo tumor resection on day 9 of course 2.

Primary Outcome Measure

Objective Tumor Response (Complete Response and Partial Response) and Progression in Participants With Stage III or IV Melanoma Following Treatment With Temsirolimus and Bevacizumab [ Time Frame: Up to 18 weeks after registration. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of Virginia Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Philadelphia, PA

By research site
Fox Chase Cancer Center· Philadelphia, PAUniversity of Virginia Cancer Center· Charlottesville, VA

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