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The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer
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Purpose
| Condition | Intervention |
|---|---|
| Lymphoma, Non-Hodgkin HIV Infections | Drug: Methotrexate Drug: Leucovorin calcium Drug: Zidovudine Drug: Dexamethasone |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Chemotherapy, Radiotherapy, and Azidothymidine for AIDS-Related Primary CNS Lymphoma |
| Estimated Enrollment: | 45 |
| Study Completion Date: | March 1990 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Patient must have negative titers for toxoplasmosis or other infectious etiology for CNS disease.
Prior Medication:
Allowed:
- Zidovudine may be continued per protocol specifications.
Exclusion Criteria
- Pathologic diagnosis of lymphoma in central nervous system (CNS) must be confirmed but no previous treatment is allowed. In participating institutions where CNS biopsies cannot be obtained, the patient may be considered eligible if space-occupying lesions have been demonstrated on computerized tomography or magnetic resonance imaging with negative titers for toxoplasmosis or negative response to empiric therapy for intracerebral toxoplasmosis and negative workup for other infectious etiology of CNS disease.
Co-existing Condition:
Patients with the following are excluded:
- Positive titers for toxoplasmosis. Positive titers for other infectious etiology of CNS disease. Acute intercurrent infection. A second active tumor other than nonmelanomatous skin cancer or Kaposi's sarcoma. Lymphomatous meningitis alone without a mass lesion in the brain.
Concurrent Medication:
Excluded:
- Acetaminophen, nonsteroidal anti- inflammatory agents, and corticosteroids other than dexamethasone.
Prior Medication:
Excluded:
- Acetaminophen, nonsteroidal anti-inflammatory agents, and corticosteroids other than dexamethasone.
- Excluded within 2 weeks of study entry:
- Immunomodulating agents.
- Excluded within 30 days of study entry:
- Any investigational agent.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00000723
| United States, Louisiana | |
| Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU | |
| New Orleans, Louisiana, United States, 70112 | |
| Study Chair: | Levine AM |
More Information
Additional Information:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000723 History of Changes |
| Other Study ID Numbers: |
ACTG 009 10985 ( Registry Identifier: DAIDS ES Registry Number ) |
| Study First Received: | November 2, 1999 |
| Last Updated: | May 29, 2012 |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
AIDS-Related Opportunistic Infections Lymphoma Methotrexate Leucovorin Dexamethasone Drug Evaluation |
Drug Therapy, Combination Combined Modality Therapy Acquired Immunodeficiency Syndrome Zidovudine Brain Neoplasms |
Additional relevant MeSH terms:
|
Lymphoma HIV Infections Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Dexamethasone acetate Dexamethasone Methotrexate BB 1101 Zidovudine Levoleucovorin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on August 16, 2017