Terminated
Chemotherapy, Radiotherapy, and Azidothymidine for AIDS-Related Primary CNS Lymphoma
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-28
45
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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 nervous system (CNS) lymphoma and to determine response rates and survival of treated patients. Also to determine if the treatment inhibits HIV replication in patients who are HIV culture and/or antigen positive and to assess the incidence of opportunistic infection in these patients 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.
CONDITIONS
Official Title
The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, United States, 70112
Status Unknown
How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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