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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00086944 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: carboplatin Drug: etoposide Drug: filgrastim Drug: ifosfamide Drug: oblimersen Drug: pegfilgrastim Drug: rituximab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I/II Study of G3139 (Genasense) in Combination With RICE Chemotherapy in Relapsed B-Cell Non-Hodgkin's Lymphoma |
Study Start Date: | May 2004 |
Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, phase I, dose-escalation study of oblimersen followed by a phase II study.
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.
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.
PROJECTED ACCRUAL: A total of 3-25 patients will be accrued for the phase I portion of this study. A total of 12-28 patients will be accrued for the phase II portion of this study. Patients will be accrued within 18 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma
Any 1 one of the following histological subtypes for phase I:
Any 1 of the following histological subtypes for phase II:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No currently active second malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Illinois | |
Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
Maywood, Illinois, United States, 60153 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Decatur Memorial Hospital Cancer Care Institute | |
Decatur, Illinois, United States, 62526 | |
Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
La Grange Memorial Hospital | |
La Grange, Illinois, United States, 60525 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Fort Wayne Medical Oncology and Hematology | |
Fort Wayne, Indiana, United States, 46885-5099 | |
United States, Michigan | |
Oncology Care Associates, PLLC | |
Saint Joseph, Michigan, United States, 49085 |
Study Chair: | Sonali M. Smith, MD | University of Chicago |
Study ID Numbers: | CDR0000371904, UCCRC-12975A, NCI-6243 |
Study First Received: | July 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00086944 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma recurrent mantle cell lymphoma recurrent grade 3 follicular lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Carboplatin Etoposide phosphate Mantle cell lymphoma Recurrence Lymphoma, large-cell |
Lymphoma, B-Cell Lymphatic Diseases Ifosfamide B-cell lymphomas Lymphoma, Non-Hodgkin Aggression Lymphoproliferative Disorders Etoposide Lymphoma Follicular lymphoma Isophosphamide mustard |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Pharmacologic Actions |