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Sponsors and Collaborators: |
British Columbia Cancer Agency National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070083 |
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 cyclophosphamide, doxorubicin, vincristine, and prednisone, use different ways to stop cancer cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of a chemotherapy drug by making cancer cells more sensitive to the drug. Combining oblimersen with rituximab and combination chemotherapy may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of oblimersen when given together with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in treating patients with stage II, stage III, or stage IV large B-cell lymphoma
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: oblimersen Drug: prednisone Drug: rituximab Drug: vincristine sulfate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of G3139 Antisense Oligonucleotide (Oblimersen) In Combination With CHOP And Rituximab In Untreated Advanced Stage Diffuse Large B Cell Lymphoma |
Study Start Date: | July 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, non-blinded, multicenter, dose-escalation study of oblimersen.
Patients receive CHOP-R* therapy comprising cyclophosphamide IV over 15-45 minutes, doxorubicin IV over 5-10 minutes, vincristine IV, and rituximab IV over 30-90 minutes on day 1 and oral prednisone on days 1-5. Patients also receive oblimersen IV continuously on days -4 to 3. Treatment repeats every 21 days for 6-8 courses in the absence of disease progression or unacceptable toxicity. Patients who discontinue treatment due to unacceptable toxicity to oblimersen may continue to receive standard therapy comprising CHOP-R.
NOTE: *Patients treated at the British Columbia Cancer Agency receive cyclophosphamide, doxorubicin, vincristine, and rituximab on days 1 and 2 and prednisone as above.
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. Once the MTD is determined, at least 10 patients are treated at that dose level.
Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-28 patients will be accrued for this study within 5-10 months.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* CD20+ diffuse large B-cell lymphoma, including any of the following stages:
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
No prior radiotherapy
Surgery
United States, California | |
Stanford Cancer Center at Stanford University Medical Center | |
Stanford, California, United States, 94305 | |
Canada, British Columbia | |
British Columbia Cancer Agency - Centre for the Southern Interior | |
Kelowna, British Columbia, Canada, V1Y 5L3 | |
British Columbia Cancer Agency - Vancouver Cancer Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Fraser Valley Cancer Centre at British Columbia Cancer Agency | |
Surrey, British Columbia, Canada, V3V 1Z2 |
Study Chair: | Richard J. Klasa, MD | British Columbia Cancer Agency |
Study ID Numbers: | CDR0000329985, BCCA-NCI-5818, NCI-5818 |
Study First Received: | October 3, 2003 |
Last Updated: | August 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00070083 |
Health Authority: | United States: Federal Government |
contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma |
Prednisone Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Rituximab Vincristine Cyclophosphamide Doxorubicin |
Lymphoma, B-Cell Lymphoma, large-cell Lymphatic Diseases B-cell lymphomas Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Anti-Inflammatory Agents Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antimitotic Agents Antibiotics, Antineoplastic |
Hormones Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic Alkylating Agents |