Search / Trial NCT00000723

The Use of Chemotherapy Plus Radiotherapy Plus Azidothymidine in Patients With AIDS-Related Lymph Node Cancer

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Terminated

Keywords

Aids Related Opportunistic Infections Lymphoma Methotrexate Leucovorin Dexamethasone Drug Evaluation Drug Therapy, Combination Combined Modality Therapy Acquired Immunodeficiency Syndrome Zidovudine Brain Neoplasms

ClinConnect Summary

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....

Gender

ALL

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.

Trial Officials

Levine AM

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

New Orleans, Louisiana, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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