BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
- Conditions
- Ovarian CancerMerkel Cell CarcinomaSCLC
- Registration Number
- NCT00346385
- Lead Sponsor
- ImmunoGen, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments these tests will be conducted at various timepoints during a patients participation in the trial
- Secondary Outcome Measures
Name Time Method Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level PK is assessed during the first cycle (21 days) of a patients participation Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM) efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle
Trial Locations
- Locations (9)
University of California San Francisco
🇺🇸San Francisco, California, 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
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
🇬🇧Sutton, England, United Kingdom
Nevada Cancer Institute
🇺🇸Las Vegas, Nevada, United States
Christie Hospital NHS Trust
🇬🇧Manchester, England, United Kingdom
The Ohio State University Cancer Center and Research Institute
🇺🇸Columbus, Ohio, United States