Trials / Completed

CompletedNCT00086944

Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma

A Phase I/II Study of G3139 (Genasense) in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkin's Lymphoma

Status: Completed
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 25 (actual)

Sponsor: National Cancer Institute (NCI) · NIH
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This phase I/II trial is studying the side effects and best dose of oblimersen when given together with rituximab and combination chemotherapy and to see how well they work in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of chemotherapy by making cancer cells more sensitive to the drugs

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.

Conditions

Interventions

Type	Name	Description
BIOLOGICAL	oblimersen sodium	Given IV
BIOLOGICAL	rituximab	Given IV
DRUG	ifosfamide	Given IV
DRUG	carboplatin	Given IV
DRUG	etoposide	Given IV
BIOLOGICAL	filgrastim	Given SC
BIOLOGICAL	pegfilgrastim	Given SC
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

Start date: 2004-05-01
Primary completion: 2006-07-01
First posted: 2004-07-12
Last updated: 2013-01-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00086944. Inclusion in this directory is not an endorsement.