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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000801
Other study ID # ACTG 252
Secondary ID ECOG E 1493
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated October 31, 2012
Est. completion date April 1998

Study information

Verified date October 2012
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date April 1998
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Filgrastim

Vincristine sulfate

Doxorubicin hydrochloride

Cyclophosphamide

Cytarabine

Dexamethasone


Locations

Country Name City State
United States Beth Israel Deaconess - West Campus Boston Massachusetts
United States ECOG Data Management Office Brookline Massachusetts
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Mount Sinai Med Ctr New York New York
United States San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California
United States San Francisco Gen Hosp San Francisco California
United States Julio Arroyo West Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Schultz C, Scott C, Sherman W, Donahue B, Fields J, Murray K, Fisher B, Abrams R, Meis-Kindblom J. Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06. J Clin Oncol. 1996 Feb;14(2):556-64. — View Citation

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