Clinical trial · Interventional
Chemotherapy and Azidothymidine, With or Without Radiotherapy, for High Grade Lymphoma in AIDS-Risk Group Members
NCT00000703CI-TRIAL-00054843completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To determine the safety and effectiveness of a combination chemotherapy-radiation-zidovudine (AZT) treatment for patients with peripheral lymphoma. Other chemotherapies have been tried in patients with AIDS related lymphomas, but the results have not been satisfactory. This study will show whether the combination of chemotherapy, radiation, and AZT is more effective and less toxic than previously used treatments.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HIV Infections | — | UNRESOLVED | — |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allopurinol | Drug | — | UNRESOLVED |
| Bleomycin sulfate | Drug | Bleomycin | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| Leucovorin calcium | Drug | Leucovorin | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria Concurrent Medication: Allowed: * Ibuprofen. * Standard antiemetic agents. * Ganciclovir therapy for sight- or life-threatening Cytomegalovirus infection. * Zidovudine and methotrexate may be resumed during ganciclovir maintenance phase. Exclusion Criteria Co-existing Condition: The following patients will be excluded from the study: * Patients with recurrent infection that may interfere with the planned protocol. * Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma. * Patients with stage IE primary central nervous system lymphoma. Concurrent Medication: Excluded: * Corticosteroids. * Aspirin. * Acetaminophen. * Nonsteroidal anti-inflammatory drugs, except ibuprofen. * Chemotherapy for infection associated with neutropenia. * Zidovudine (AZT) for infection associated with neutropenia. * Investigational therapies, except ganciclovir therapy for sight- or life-threatening cytomegalovirus infection. * AZT and methotrexate will be suspended during induction therapy with ganciclovir. The following patients will be excluded from the study: * Patients with recurrent infection that may interfere with the planned protocol. * Patients with a second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma. * Patients with stage IE primary central nervous system lymphoma. Prior Medication: Excluded: * Zidovudine (AZT). * Excluded within 2 weeks of study entry: * Immunomodulating agents. * Antiretroviral therapy prior to diagnosis of lymphoma. Patients must demonstrate the following clinical and laboratory findings: * Any stage of the disease, including stage I. * Newly diagnosed, previously untreated high-grade lymphoma. * Presence of measurable tumor parameter(s). * Adequate hepatic, renal, and bone marrow function.
References
Publications (3)
- BACKGROUNDSaag MS, Emini EA, Laskin OL, Douglas J, Lapidus WI, Schleif WA, Whitley RJ, Hildebrand C, Byrnes VW, Kappes JC, et al. A short-term clinical evaluation of L-697,661, a non-nucleoside inhibitor of HIV-1 reverse transcriptase. L-697,661 Working Group. N Engl J Med. 1993 Oct 7;329(15):1065-72. doi: 10.1056/NEJM199310073291502. PMID 7690462
- BACKGROUNDLevine AM, Wernz JC, Kaplan L, Rodman N, Cohen P, Metroka C, Bennett JM, Rarick MU, Walsh C, Kahn J, et al. Low-dose chemotherapy with central nervous system prophylaxis and zidovudine maintenance in AIDS-related lymphoma. A prospective multi-institutional trial. JAMA. 1991 Jul 3;266(1):84-8. PMID 1710673
- BACKGROUNDICDB/89653727. Levine AM, et al. Low dose chemotherapy with CNS prophylaxis and zidovudine (AZT) maintenance for aids-related lymphoma: preliminary results of a multi-institutional study. Proc Annu Meet Am Soc Clin Oncol. 1989 8:A18