The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer
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|ClinicalTrials.gov Identifier: NCT00000723|
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : May 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Non-Hodgkin HIV Infections||Drug: Methotrexate Drug: Leucovorin calcium Drug: Zidovudine Drug: Dexamethasone||Not Applicable|
Results of radiation given to patients with AIDS-related high-grade CNS lymphoma have been disappointing, with short survival times due to infection complications. However, complete response has been documented after radiation in some patients. High-dose MTX will be used to improve the possibility of a greater antineoplastic response than that obtained by radiation alone. Since the underlying immunodeficiency state is not affected by therapy directed against the lymphoma, patients are still prone to life-threatening opportunistic infections or relapse of lymphomatous disease within the CNS. Accordingly, AZT will also be used in an attempt to alter the overall natural history of the disease.
Radiation begins on day 1 of therapy. Patients receive dexamethasone orally (PO) or by intravenous injection (IV) on days 1-10. MTX IV over 6 hours weekly for a total of 4 doses starts 1 week after completion of the cranial radiation. Leucovorin (LCV) IV or PO begins 6 hours after MTX has been completed over 6 hours for 8 doses. AZT while awake starts on day 1 of therapy and continues for 52 weeks. Patients are reevaluated with computerized tomography (CT) or magnetic resonance imaging (MRI) scan of the brain at conclusion of radiation therapy and systemic treatment, 6 and 10 weeks respectively. If there is a complete or partial response (CR or PR), patient will remain on study and continue to receive AZT; if stable disease or no response, patient will be taken off study. Reevaluation at 16 weeks from start of study will be done. If CR or PR, the patient will continue AZT for 1 year. If there is no change or progression of disease, or if the patient develops evidence of systemic lymphomatous disease, patient will be taken off study.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||45 participants|
|Official Title:||Chemotherapy, Radiotherapy, and Azidothymidine for AIDS-Related Primary CNS Lymphoma|
|Actual Study Completion Date :||March 1990|
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): NCT00000723
|United States, Louisiana|
|Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU|
|New Orleans, Louisiana, United States, 70112|
|Study Chair:||Levine AM|