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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000801

Collaborator

(none)

Enrollment

Locations

4.7

Patients Per Site

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin HIV Infections	Drug: Filgrastim Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone	Phase 2

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 chemotherapy with cyclophosphamide, doxorubicin, vincristine, dexamethasone, and G-CSF. Cyclophosphamide, doxorubicin, and vincristine are administered intravenously on day

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Apr 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	ECOG Data Management Office	Brookline	Massachusetts	United States	02146
6	Mount Sinai Med Ctr	New York	New York	United States	10029
7	Julio Arroyo	West Columbia	South Carolina	United States	29169