Investigation of Safety, Tolerability and Maximum Tolerated Dose (MTD) of BI 2536 in Patients With Recurrent Advanced Aggressive Non-Hodgkin's Lymphoma (NHL)
RATIONALE: BI 2536 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase I trial is studying the side effects and best dose of BI 2536 in treating patients with refractory or relapsed advanced non-Hodgkin's lymphoma.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Phase I Single Dose Escalation Study of BI 2536 Administered Intravenously in Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma|
- Maximum tolerated dose as measured by CTCAE v3.0 at days 1-22 of each course [ Time Frame: up to 22 days of each course ] [ Designated as safety issue: No ]
- Dose-limiting toxicity as measured by CTCAE v3.0 at days 1-22 of each course [ Time Frame: up to 22 days of each course ] [ Designated as safety issue: No ]
- Objective tumor response by CT scan or MRI as measured by RECIST criteria on day 22 of each even numbered course [ Time Frame: day 22 of every second course ] [ Designated as safety issue: No ]
- Pharmacokinetics as measured in blood samples at days 1, 2, 3, and 8 during first course and on day 1 of each subsequent course [ Time Frame: day 22 of each course ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
- Determine the maximum tolerated dose of BI 2536 in patients with refractory or relapsed advanced aggressive non-Hodgkin's lymphoma.
- Determine the safety and tolerability of this drug in these patients.
- Determine the pharmacokinetic profile of this drug in these patients.
- Determine, preliminarily, the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, open-label, uncontrolled, multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BI 2536 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity during the first treatment course. Up to 24 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically until disease progression or initiation of another cancer treatment.
PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study.
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Texas|
|M. D. Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||Julie M. Vose, MD||University of Nebraska|