HIV Infections Clinical Trial
Official title:
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
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 with CHOD (cyclophosphamide, doxorubicin, vincristine, and
dexamethasone) plus filgrastim (granulocyte-colony stimulating factor; G-CSF) and external
beam irradiation. To determine other clinical markers present in this patient population.
Combined modality therapy may prove of benefit for patients with AIDS-related primary CNS
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.
;
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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