Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Grade 3 Follicular Lymphoma
Recurrent Mantle Cell Lymphoma
Biological: oblimersen sodium
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Study of G3139 (Genasense) in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkin's Lymphoma|
- Toxicity graded using the NCI CTCAE version 3.0 [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
- Complete and partial response rate according to the International Workshop Criteria [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: From the time measurement criteria are met for CR/CRu/PR until the first date that PD is objectively documented, assessed up to 3 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From the first day of therapy to the date of death, assessed up to 3 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: From the first day of treatment until the date PD or death is first reported, assessed up to 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2004|
|Primary Completion Date:||July 2006 (Final data collection date for primary outcome measure)|
Experimental: Treatment (genase, combination chemotherapy)
See detailed description.
Biological: oblimersen sodium
Other Names:Biological: rituximab
Other Names:Drug: ifosfamide
Other Names:Drug: carboplatin
Other Names:Drug: etoposide
Other Names:Biological: filgrastim
Other Names:Biological: pegfilgrastim
Other Names:Other: laboratory biomarker analysis
I. Determine the maximum tolerated dose of oblimersen when given in combination with rituximab, ifosfamide, carboplatin, and etoposide in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma.
II. Determine the safety and toxicity of this regimen in these patients. III. Determine the complete and partial response rate in patients treated with this regimen.
I. Determine the duration of response, overall survival, and time to progression in patients treated with this regimen.
II. Determine the effect of this regimen on hematopoietic stem cell kinetics and yield from these patients.
OUTLINE: This is a multicenter, phase I, dose-escalation study of oblimersen followed by a phase II study.
Phase I: Patients receive GRICE comprising oblimersen IV continuously on days 1-5, rituximab IV, ifosfamide IV continuously over 24 hours, and carboplatin IV over 1 hour on day 4, and etoposide IV over 30 minutes once daily on days 4-6. Treatment repeats every 14 days for 3 courses. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 7 and continuing until blood counts recover OR one dose of pegfilgrastim SC on day 7 of courses 1 and 2. For course 3, all patients receive G-CSF SC twice daily beginning on day 7 and continuing until stem cell collection is complete. Patients with responding disease who are not eligible for autologous SCT may receive up to 8 total courses of GRICE or 2 additional courses beyond maximal response. Patients with responding disease to GRICE who are eligible for autologous SCT are removed from the study and undergo autologous SCT off study. Cohorts of 3-6 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 3 or 2 of 6 patients experience dose-limiting toxicity.
Phase II: Patients receive oblimersen at the MTD determined in phase I and rituximab, ifosfamide, carboplatin, and etoposide followed by G-CSF or pegfilgrastim as in phase I. In both phases, treatment continues in the absence of disease progression, unacceptable toxicity, or the patient becomes a candidate for autologous SCT. Patients are followed for survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086944
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Sonali Smith||University of Chicago Comprehensive Cancer Center|