BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901|
- Safety and tolerability assessed by toxicity evaluation and prothrombin time assessments [ Time Frame: these tests will be conducted at various timepoints during a patients participation in the trial ] [ Designated as safety issue: Yes ]
- Pharmacokinetics assessed by measuring intact conjugate and total huN901 antibody concentration for each time point and dose level [ Time Frame: PK is assessed during the first cycle (21 days) of a patients participation ] [ Designated as safety issue: No ]
- Efficacy assessed by measuring response (complete or partial response) and biomarker levels of neuron-specific enolase and soluble neural cell adhesion molecules (NCAM) [ Time Frame: efficacy is assessed every 2 cycles during a patients participation while other blood tests are taken during every cycle ] [ Designated as safety issue: No ]
|Study Start Date:||March 2002|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
- Determine the safety and tolerability of BB-10901
- Determine the maximum tolerated dose of this drug in these patients.
- 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.
|United States, California|
|University of California San Francisco|
|San Francisco, California, United States, 94115|
|United States, Nevada|
|Nevada Cancer Institute|
|Las Vegas, Nevada, United States, 89135|
|United States, Ohio|
|The Ohio State University Cancer Center and Research Institute|
|Columbus, Ohio, United States|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1023|
|Christie Hospital NHS Trust|
|Manchester, England, United Kingdom, M20 9BX|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Study Chair:||Paul C. Lorigan, MD||Christie Hospital NHS Foundation Trust|