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


Phase 2
16 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin, HIV Infections

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Trial Information

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


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 chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and
G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day
1. Dexamethasone is administered intravenously on day 1 and then orally thereafter with
gradual discontinuation. G-CSF is administered subcutaneously daily beginning on day 2 and
continuing for a total of 10 days or until blood counts have recovered to an acceptable
level. Patients with evidence of cancer cells in their cerebrospinal fluid (CSF) will
receive chemotherapy with intrathecal cytarabine twice weekly until no further evidence of
cancer cells is found in the CSF, then once weekly for 6 weeks, and then monthly for 10
months. Seven to ten days following completion of one cycle of chemotherapy, patients
undergo radiotherapy to the brain at a dose of 2.5 Gy daily for 5 days per week for
approximately 4 weeks. Total dose to the whole brain and meninges is 30.0 Gy in 12
fractions, and total dose to the primary boost volume is 10.0 Gy in 4 fractions. During
therapy, blood is drawn weekly and brain scans are performed every 3-12 weeks. An initial
CSF sample will be obtained by lumbar puncture.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Principal Investigator

Krigel RL

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 252

NCT ID:

NCT00000801

Start Date:

Completion Date:

April 1998

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Vincristine
  • Cyclophosphamide
  • Cytarabine
  • Dexamethasone
  • Doxorubicin
  • Granulocyte Colony-Stimulating Factor
  • Combined Modality Therapy
  • Acquired Immunodeficiency Syndrome
  • Antineoplastic Agents, Combined
  • Brain Neoplasms
  • Lymphoma, High-Grade
  • Lymphoma, Intermediate-Grade
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

San Francisco Gen HospSan Francisco, California  941102859
Julio ArroyoWest Columbia, South Carolina  29169
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, California  941102859
Univ of Colorado Health Sciences CtrDenver, Colorado  80262
Beth Israel Deaconess - West CampusBoston, Massachusetts  02215
Mount Sinai Med CtrNew York, New York  10029
ECOG Data Management OfficeBrookline, Massachusetts  02146