A Phase I/II Study of G3139 (Genasense) in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkin's Lymphoma
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
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
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity graded using the NCI CTCAE version 3.0
Up to 3 years
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
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