Status:
TERMINATED
The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Lymphoma, Non-Hodgkin
HIV Infections
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
To determine the safety and toxicity of high-dose systemic methotrexate (MTX) and dexamethasone (DEX) combined with zidovudine (AZT) and brain irradiation in patients with AIDS-related primary central...
Detailed Description
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 ...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
March 1 1990
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00000723
End Date
March 1 1990
Last Update
October 28 2021
Active Locations (1)
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1
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States, 70112