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Phase I/II Study of CTX/VCR/DOX/VP-16 with ddI, G-CSF, and CNS Prophylaxis/Therapy in Patients with AIDS-Associated non-Hodgkin's Lymphoma (Summary Last Modified 07/92)
Basic Trial Information
Objectives I. Determine the tolerable dose and toxicities, especially hematologic and neurologic, of cyclophosphamide/vincristine/doxorubicin/etoposide administered with dideoxyinosine (ddI) and granulocyte colony stimulating factor (G-CSF) to patients with AIDS-associated non-Hodgkin's lymphoma. II. Determine prospectively the efficacy of infusional chemotherapy/ddI/G-CSF in these patients. III. Determine the efficacy of CNS prophylaxis with intrathecal methotrexate in these patients. IV. Determine the effect of the regimen on markers of HIV infection and on immune competence. V. Investigate the molecular and cellular biology and cytogenetics of AIDS-associated non-Hodgkin's lymphoma, with special attention to the effect of treatment on cytokine production by lymphoma cells and circulating lymphocytes. Entry Criteria Disease Characteristics: Biopsy-proven, intermediate- or high-grade non-Hodgkin's lymphoma in patients with positive HIV serology The following histologies are included: Small non-cleaved cell lymphoma (Burkitt's or non-Burkitt's) Large cell lymphoma Large cell immunoblastic lymphoma Stages I-IV, preferably without prior treatment No primary CNS lymphoma No visceral Kaposi's sarcoma Prior/Concurrent Therapy: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy for NHL No prior cytotoxic chemotherapy for Kaposi's sarcoma Endocrine therapy: Not specified Radiotherapy: Prior limited radiotherapy allowed at the discretion of the principal investigator No more than 3,000 rads to 1 previous radiation port Surgery: Prior surgery allowed (patients who are NED following surgery are also eligible) Other: Prior antiretroviral therapy is expected and allowed Patients with known intolerance to ddI may be entered at the discretion of the principal investigator and will receive zidovudine or other antiretroviral therapy Patient Characteristics: Age: 18 and over Performance status: Karnofsky greater than 50% (unless decreased performance status is attributable to untreated lymphoma) Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No active opportunistic infection requiring chronic therapy No second malignancy except: Nonmelanomatous skin cancer Kaposi's sarcoma limited to the skin No pregnant women Expected Enrollment It is anticipated that 50 patients will be entered over 2 or 3 years. Interim analysis is planned after entry of 14 patients. Outline Nonrandomized study. Chemotherapy: Antiretroviral Therapy plus 4-Drug Combination Chemotherapy with Hematologic Toxicity Attenuation. Dideoxyinosine, ddI, NSC-612049 (or Zidovudine, ZDV, NSC-602670); plus Cyclophosphamide, CTX, NSC-26271; Vincristine, VCR, NSC-67574; Doxorubicin, DOX, NSC-123127; Etoposide, VP-16, NSC-141540; with Granulocyte Colony Stimulating Factor (Amgen), G-CSF, NSC-614629. CNS Prophylaxis/Therapy: Intrathecal Chemotherapy plus, as indicated, Radiotherapy. Intrathecal Methotrexate, IT MTX, NSC-740; plus, as indicated, whole-brain irradiation (equipment unspecified) and, as appropriate, an involved-field boost. 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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