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Phase I/II Pilot Study of Cytotoxic Chemotherapy with CTX/DOX/VP-16/VCR/MTX/CF plus Recombinant GM-CSF, AZT, and Inhaled Pentamidine in Patients with AIDS-Associated non-Hodgkin's Lymphoma (Summary Last Modified 06/90)
Basic Trial Information
Objectives I. Determine prospectively the maximum tolerated chemotherapy dose and the toxicity, response rate, and survival produced by cytotoxic chemotherapy (cyclophosphamide/doxorubicin/etoposide/methotrexate/vincristine with leucovorin rescue), azidothymidine, and granulocyte-macrophage colony stimulating factor combined with CNS prophylaxis (or treatment) with intrathecal methotrexate and cytarabine in patients with AIDS-associated non-Hodgkin's lymphoma. II. Investigate the molecular and cellular biology, cytogenetics, and cell surface markers of AIDS-associated non-Hodgkin's lymphoma. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients 18 years of age and older who are HIV-positive (with or without a previous diagnosis of AIDS or ARC as defined by the CDC) and who have biopsy-proven, Stage I/II/III/IV intermediate- or high-grade non-Hodgkin's lymphoma (Working Classification), including small non-cleaved cell lymphoma, large cell lymphoma, large cell immunoblastic lymphoma, and Burkitt's lymphoma. Diagnosis must be confirmed by the NCI Laboratory of Pathology. Patients with primary CNS lymphoma are excluded, as are those with pulmonary Kaposi's sarcoma or known extensive gastrointestinal Kaposi's sarcoma. Patients must be free of clinically active opportunistic infection, including CMV retinitis, CNS toxoplasmosis, active M. tuberculosis (on treatment), and P. carinii pneumonia treated for less than 2 weeks; those on DHPG maintenance and those with progressive multifocal leukoencephalopathy are ineligible, and those with known MAI involving the bone marrow may be excluded. Previously untreated patients are preferred, but patients who have received limited prior radiotherapy may be eligible at the discretion of the principal investigator; prior cytotoxic chemotherapy is not allowed. Disease that can be measured or evaluated by physical examination or diagnostic test is required, and patients must have a Karnofsky performance status of at least 30% and a life expectancy of at least 12 weeks. Patients with a coexistent second malignancy, other than basal or squamous cell carcinoma and Kaposi's sarcoma (except as noted above), are ineligible. Pregnancy excludes. Expected Enrollment It is expected that 14 patients will be accrued per year. Outline Nonrandomized study. All patients receive treatment on Regimen A and receive CNS prophylaxis or CNS treatment on Regimen B. Regimen A: 5-Drug Combination Chemotherapy with Leucovorin Rescue and Hematologic Toxicity Attenuation plus Anti-HIV Therapy plus Prophylaxis for P. carinii pneumonia. Cyclophosphamide, CTX, NSC-26271; Etoposide, VP-16, NSC-141540; Doxorubicin, DOX, NSC-123127; Vincristine, VCR, NSC-67574; Methotrexate, MTX, NSC-740; with Leucovorin calcium, Citrovorum Factor, CF, NSC-3590; and Granulocyte-Macrophage Colony Stimulating Factor (Schering), GM-CSF, NSC-617589; plus Zidovudine, Azidothymidine, AZT, NSC-602670; plus Pentamidine, NSC-620107. Regimen B: CNS Prophylaxis/Treatment. Intrathecal Cytarabine, IT ARA-C, NSC-63878; Intrathecal Methotrexate, IT MTX; whole-brain irradiation (equipment unspecified). Trial Lead Organizations NCI - Center for Cancer Research
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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