Bevacizumab With or Without MEDI-522 in Treating Patients With Unresectable or Metastatic Kidney Cancer

Part of paid clinical trials in Marysville, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00684996
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Recurrent Renal Cell Cancer
  • Renal Cell Carcinoma
  • Stage III Renal Cell Cancer
  • Stage IV Renal Cell Cancer

Eligibility Criteria

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

Interventions

  • etaracizumab — DRUG
    Given IV
  • bevacizumab — BIOLOGICAL
    Given IV

Study Details

This phase I/randomized phase II trial is studying the side effects and best dose of bevacizumab and to see how well it works when given together with or without MEDI-522 in treating patients with unresectable or metastatic kidney cancer. Monoclonal antibodies, such as bevacizumab and MEDI-522, 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 and MEDI-522 may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether bevacizumab is more effective when given together with or without MEDI-522 in treating kidney cancer.

Key Dates

First listed
May 28, 2008
Start date
Jun 30, 2008
Status verified
Apr 2013
Primary completion
Oct 31, 2010
Completion
Oct 31, 2010

Study Design

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

Arms

  • Active Comparator: Phase II Arm I
    Patients receive bevacizumab (10mg/kg) IV over 30-90 minutes on days 1 and 15.
  • Active Comparator: Phase II Arm II
    Patients receive bevacizumab IV as in arm I at the RPTD determined in phase I, and humanized monoclonal antibody MEDI-522 (8mg/kg) IV over 30 minutes on days 1, 8, 15, and 22.

Primary Outcome Measure

Maximum Tolerated Dose of Bevacizumab , Based on Incidence of Dose-limiting Toxicity (DLT) Graded According to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 (Phase I) [ Time Frame: Up to 8 weeks ]

Locations (5)

FacilityCityStateZIPSite coordinators
Fremont - Rideout Cancer CenterMarysvilleCalifornia95901-
University of California at Davis Cancer CenterSacramentoCalifornia95817-
University of MichiganAnn ArborMichigan48109-
Novant Health Presbyterian Medical CenterCharlotteNorth Carolina28204-
SWOGPortlandOregon97239-

Find similar trials in Marysville, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Fremont - Rideout Cancer Center· Marysville, CAUniversity of California at Davis Cancer Center· Sacramento, CAUniversity of Michigan· Ann Arbor, MINovant Health Presbyterian Medical Center· Charlotte, NCSWOG· Portland, OR

Related Studies