Phase I/II Study of G3139 (Genasense) in Patients With Waldenstrom's Macroglobulinemia
PRIMARY OBJECTIVES:
I. To determine the maximally tolerated dose (MTD) and recommended dosing for Genasense in
patients with relapsed or refractory WM following prior chemotherapy. (Phase I) II. To
determine the response rate to Genasense in patients with relapsed or refractory WM
following prior chemotherapy.
III. To determine the safety of Genasense in patients with relapsed or refractory WM
following prior chemotherapy.
IV. To describe possible clinical benefit from Genasense treatment of relapsed or refractory
WM including duration of response, survival, erythropoietin use, improvement in hemoglobin >
11 g/dl, and Improvement in platelet count > 100,000/mm^3.
OUTLINE: This is a multicenter, dose-escalation study.
Phase I: Patients receive oblimersen IV continuously on days 1-7. Treatment repeats every 3
weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 1-6 patients receive escalating doses of oblimersen 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.
Phase II: Patients receive treatment as in phase I at the MTD of oblimersen. Patients are
followed every 3 months for 2 years.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose determined by the number of dose-limiting toxicity incidents graded according to CTC standard toxicity (Phase I)
Hematologic dose-limiting toxicity measures will be assessed using the continuous variables as the outcome measures (primarily nadir and percent change from baseline values) as well as categorization.
21 days
Yes
Morie Gertz
Principal Investigator
Mayo Clinic
United States: Food and Drug Administration
NCI-2012-01437
NCT00062244
May 2003
Name | Location |
---|---|
Howard University Hospital | Washington, District of Columbia 20060 |
Johns Hopkins University | Baltimore, Maryland 21205 |
Mayo Clinic | Rochester, Minnesota 55905 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |