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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma  Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
For Condition: anaplastic large cell lymphoma,AIDS-related diffuse small cleaved cell lymphoma,AIDS-related immunoblastic large cell lymphoma,AIDS-related diffuse large cell lymphoma,AIDS-related lymphoblastic lymphoma,AIDS-related small noncleaved cell lymphoma,AIDS-related diffuse mixed cell lymphoma,AIDS-related peripheral/systemic lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients with AIDS -related lymphoma.
Details: OBJECTIVES: I. Determine the one year survival and complete response rate of patients treated with doxorubicin HCl liposome/cyclophosphamide/vincristine/prednisone (Doxil-CVP) for AIDS-related lymphoma. II. Evaluate the toxicity of a combination chemotherapy regimen, Doxil-CVP, in this patient population. III. Evaluate the progression free and overall survival after treatment with Doxil-CVP in this patient population. IV. Evaluate the effects of treatment with Doxil-CVP on plasma viral mRNA levels, CD4+ lymphocyte count, and the incidences and types of opportunistic infections in this patient population. PROTOCOL OUTLINE: Patients are stratified according to disease characteristics. All patients receive a 30 minute infusion of doxorubicin HCl liposome IV, cyclophosphamide IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Filgrastim (G-CSF) is administered subcutaneously starting on day 6 and continues until the absolute neutrophil count is at least 10,000/mm3. Treatment courses are repeated every 21 days. Patients with lymphomatous bone marrow involvement and/or category J lymphoma receive cytarabine and methotrexate intrathecally weekly for 4 weeks. Patients with lymphomatous meningitis receive whole brain irradiation and an alternating intrathecal chemotherapy regimen. A minimum of 4 and a maximum of 8 courses are administered. Patients are removed from the study for progressive disease, stable disease after 4 courses, a life threatening infection that would delay treatment for more than 6 weeks, or any delay, except due to neutropenia, in chemotherapy treatment for more than 6 weeks. Patients who achieve a complete response receive an additional 2 courses of therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and annually thereafter. PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed AIDS-related non-Hodgkin's lymphoma of the intermediate or high grade histologic types; Anaplastic large cell lymphoma allowed - Must be HIV positive - Must have at least one objective measurable or evaluable disease parameter - No parenchymal CNS involvement by lymphoma (meningeal lymphoma allowed) [A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.] --Prior/Concurrent Therapy-- - Biologic therapy: At least 5 days since interferon therapy - Chemotherapy: No prior cytotoxic chemotherapy except for mucocutaneous Kaposi's sarcoma; At least 12 months since cytotoxic chemotherapy for Kaposi's sarcoma - Endocrine therapy: Prior steroids allowed; No concurrent steroid therapy greater than 5 mg prednisone (or equivalent) per day - Radiotherapy: No prior radiotherapy except for mucocutaneous Kaposi's sarcoma - Surgery: Not specified - Other: No concurrent zidovudine (AZT); Concurrent antiretroviral medications other than AZT allowed --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: (Except patients with lymphomatous marrow involvement) Absolute neutrophil count at least 1000/mm3; Platelet count at least 50,000/mm3 - Hepatic: Bilirubin no greater than 5.0 mg/dL - Renal: Creatinine less than 3.0 mg/dL - Cardiovascular: Patients with history of heart disease, evidence of congestive heart failure, radiographic evidence of cardiomegaly, or electrocardiographic evidence of a prior myocardial infarction must have LVEF at least at lower limit of normal - Neurologic: No grade 3 or greater peripheral neuropathy - Other: No prior or concurrent malignancy other than Kaposi's sarcoma, curatively treated basal cell or squamous cell carcinoma of the skin, or curatively treated carcinoma in situ of the cervix; Not pregnant or nursing; Fertile patients must use effective contraception; No history of sensitivity to E. coli-derived proteins
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MatthewVolm, Study Chair, Eastern Cooperative Oncology Group
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, 10466
United States
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto, California, 94304
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Additional Information:
Study ID Numbers: CDR0000066385; E-3D97
Study Start Date: February 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003388
Other Aids-Related Diffuse Mixed Cell Lymphoma Studies:
1. Interleukin-12 Following Chemotherapy in Treating Patients With Refractory HIV-Associated Non-Hodgkin's Lymphoma
2. Combination Chemotherapy, Radiation Therapy, and Antiviral Therapy in Treating Patients With AIDS-Related Lymphoma
3. Gallium Nitrate in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
4. Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
5. Combination Chemotherapy in Treating Patients With AIDS-Related Non-Hodgkin's Lymphoma
Related Studies:
Other AIDS-related diffuse mixed cell lymphoma Clinical Trials
Other California Clinical Trials
Other Stanford Clinical Trials
Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma
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