Status:

COMPLETED

Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Lymphoma, Non-Hodgkin

HIV Infections

Eligibility:

All Genders

16+ years

Phase:

PHASE2

Brief Summary

To estimate the response rate, overall and disease-free survival, toxicities, factors associated with outcome, and effect on quality of life in patients with AIDS-related primary CNS lymphoma treated ...

Detailed Description

Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS lymphoma. Patients who upon staging workup are found to be without systemic involvement undergo one cycle of ...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication: Required:

  • PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine.
  • Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches.
  • Antiretroviral agent available by therapy IND.
  • MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3).

Patients must have:

  • HIV infection.
  • Primary CNS lymphoma with NO systemic involvement.

Prior Medication:

Allowed:

  • Prior corticosteroids.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin.
  • Active uncontrolled infection.
  • Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration.
  • Active heart disease (congestive heart failure or heart block greater than first degree on EKG).

Concurrent Medication:

Excluded:

  • Any investigational agent other than antiretroviral agents available by therapy IND.

Patients with the following prior conditions are excluded:

  • No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin.
  • No new infectious complications within the past 2 weeks that require a change in antibiotics.
  • History of myocardial infarction within the past 3 months.

Prior Medication:

Excluded:

  • Prior chemotherapy other than for Kaposi's sarcoma.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

April 1 1998

Estimated Enrollment :

33 Patients enrolled

Trial Details

Trial ID

NCT00000801

End Date

April 1 1998

Last Update

November 1 2012

Active Locations (7)

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Page 1 of 2 (7 locations)

1

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States, 941102859

2

San Francisco Gen Hosp

San Francisco, California, United States, 941102859

3

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States, 80262

4

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States, 02215