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Chemotherapy, Radiotherapy, and Azidothymidine for AIDS-Related Primary CNS Lymphoma


N/A
18 Years
70 Years
Not Enrolling
Both
Lymphoma, Non-Hodgkin, HIV Infections

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Trial Information

Chemotherapy, Radiotherapy, and Azidothymidine for AIDS-Related Primary CNS Lymphoma


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Levine AM

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 009

NCT ID:

NCT00000723

Start Date:

Completion Date:

March 1990

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • AIDS-Related Opportunistic Infections
  • Lymphoma
  • Methotrexate
  • Leucovorin
  • Dexamethasone
  • Drug Evaluation
  • Drug Therapy, Combination
  • Combined Modality Therapy
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Brain Neoplasms
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU New Orleans, Louisiana  70112