Spots Global Cancer Trial Database for BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
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Trial Identification
Brief Title: BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
Official Title: A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901
Study ID: NCT00346385
Interventions
Study Description
Brief Summary: RATIONALE: Monoclonal antibodies, such as BB-10901, 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. PURPOSE: This phase I trial is studying the side effects and best dose of BB-10901 in treating patients with relapsed or refractory solid tumors.
Detailed Description: OBJECTIVES: Primary * Determine the safety and tolerability of BB-10901 * Determine the maximum tolerated dose of this drug in these patients. Secondary * Determine the pharmacokinetics of this drug in these patients. * Determine the efficacy of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.\* Treatment repeats every 21 days NOTE: \*Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the independent Safety Review Board. Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6 patients experience dose-limiting toxicity in course 1. Up to 40 patients are treated at the MTD. After completion of study treatment, patients are followed for short term and long term follow up and survival. PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Francisco, San Francisco, California, United States
Nevada Cancer Institute, Las Vegas, Nevada, United States
The Ohio State University Cancer Center and Research Institute, Columbus, Ohio, United States
Oklahoma University, Oklahoma City, Oklahoma, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Christie Hospital NHS Trust, Manchester, England, United Kingdom
Cancer Research Centre at Weston Park Hospital, Sheffield, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey, Sutton, England, United Kingdom
Contact Details
Name: Paul C. Lorigan, MD
Affiliation: The Christie NHS Foundation Trust
Role: STUDY_CHAIR
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