This phase I/II trial is studying the side effects and best dose of oblimersen and to see how well it works in treating patients with relapsed or refractory Waldenstrom's macroglobulinemia. Biological therapies such as oblimersen may interfere with the growth of the cancer cells and slow or stop the growth of 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Given IV
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
University of Maryland Greenebaum Cancer Center
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.
Time frame: 21 days
Adverse events that are classified as either possibly, probably, or definitely related to study treatment (Phase II)
The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.
Time frame: Up to 2 years
Proportion of overall confirmed responses (CR + PR) associated with G3139 (Phase II)
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
Time frame: 6 months
Time to progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to the time of progression, assessed up to 2 years
Overall survival
The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Time frame: Time from registration to death due to any cause, assessed up to 2 years
Duration of response
Time frame: From the documentation of response until the date of progression, assessed up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Baltimore, Maryland, United States
Johns Hopkins University
Baltimore, Maryland, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States