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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000801 |
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 | Intervention | Phase |
---|---|---|
Lymphoma, Non-Hodgkin HIV Infections |
Drug: Filgrastim Drug: Vincristine sulfate Drug: Doxorubicin hydrochloride Drug: Cyclophosphamide Drug: Cytarabine Drug: Dexamethasone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Efficacy Study |
Official Title: | Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma |
Estimated Enrollment: | 33 |
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication: Required:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
San Francisco AIDS Clinic / San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Massachusetts | |
Beth Israel Deaconess - West Campus | |
Boston, Massachusetts, United States, 02215 | |
ECOG Data Management Office | |
Brookline, Massachusetts, United States, 02146 | |
United States, New York | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Krigel RL | |
Study Chair: | Von Roenn J |
Study ID Numbers: | ACTG 252, ECOG E 1493 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000801 |
Health Authority: | United States: Federal Government |
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 |
Dexamethasone Sexually Transmitted Diseases, Viral Immunoproliferative Disorders Acquired Immunodeficiency Syndrome Vincristine Cyclophosphamide Doxorubicin Immunologic Deficiency Syndromes Central nervous system lymphoma, primary Virus Diseases |
Brain Neoplasms Lymphatic Diseases HIV Infections Sexually Transmitted Diseases Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Retroviridae Infections Dexamethasone acetate Cytarabine |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Slow Virus Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Antibiotics, Antineoplastic Infection Hormones Therapeutic Uses |
Alkylating Agents RNA Virus Infections Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Gastrointestinal Agents Antimitotic Agents Glucocorticoids Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Autonomic Agents Tubulin Modulators |