Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00004039 |
|
Recruitment Status :
Withdrawn
(No patient accruals)
First Posted : August 5, 2004
Last Update Posted : August 19, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus interferon alfa or rituximab in treating patients who have high risk stage III or stage IV lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: recombinant interferon alfa Biological: rituximab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate | Phase 2 |
OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor response rate and duration of response for these regimens in these patients. III. Determine the failure free survival and overall survival for these patients on these regimens. IV. Compare the response rate and survival rate of these patients on these regimens to similar patients treated in published studies. V. Compare the toxicities of these regimens in these patients. VI. Determine the quality of life of these patients on these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms: Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma |
| Study Start Date : | June 1998 |
| Actual Primary Completion Date : | January 2000 |
| Actual Study Completion Date : | January 2000 |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed high risk (stage III or IV) indolent or intermediate (stage II to IV) B-cell lymphoma Small cleaved cell lymphoma Waldenstrom's macroglobulinemia Follicular small cleaved cell or mixed cell Follicular large cell Diffuse Immunoblastic High risk is defined as: Increased LDH OR Increased beta-2-microglobulin OR B symptoms OR Bulky disease of greater than 7 cm in diameter OR Extranodal disease other than blood or bone marrow involvement OR Mantle zone histology At least 1 lymph node or visceral lesion at least 2 cm in diameter
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No active infection or other medical condition this is lifethreatening Not pregnant Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004039
| United States, California | |
| Hoag Memorial Hospital Presbyterian | |
| Newport Beach, California, United States, 92658 | |
| Study Chair: | Robert O. Dillman, MD, FACP | Cancer Biotherapy Research Group |
| Responsible Party: | Robert O. Dillman, MD, Hoag Memorial Hospital Presbyterian |
| ClinicalTrials.gov Identifier: | NCT00004039 |
| Other Study ID Numbers: |
CDR0000066762 CBRG-9807 NCI-V98-1494 |
| First Posted: | August 5, 2004 Key Record Dates |
| Last Update Posted: | August 19, 2015 |
| Last Verified: | August 2015 |
|
Waldenstrom macroglobulinemia stage II grade 3 follicular lymphoma stage II adult diffuse small cleaved cell lymphoma stage II adult diffuse mixed cell lymphoma stage II adult diffuse large cell lymphoma stage II adult immunoblastic large cell lymphoma stage II adult Burkitt lymphoma stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III adult diffuse small cleaved cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse large cell lymphoma |
stage III adult immunoblastic large cell lymphoma stage III adult Burkitt lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse large cell lymphoma stage IV adult immunoblastic large cell lymphoma stage IV adult Burkitt lymphoma stage III mantle cell lymphoma stage IV mantle cell lymphoma |
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Interferons Interferon-alpha Prednisone Cyclophosphamide Rituximab Doxorubicin Liposomal doxorubicin Vincristine |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents |