Completed

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

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What is being tested

Filgrastim

+ Vincristine sulfate
+ Doxorubicin hydrochloride
Drug
Who is being recruted

Lymphoma, Non-Hodgkin

+ HIV Infections
Over 16 Years
How is the trial designed

Treatment Study

Phase 2
Interventional

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2012
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePhase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 1, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
33 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 16 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Lymphoma, Non-Hodgkin
HIV Infections
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.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 7 locations
Suspended
San Francisco AIDS Clinic / San Francisco Gen HospSan Francisco, United StatesSee the location
Suspended
San Francisco Gen HospSan Francisco, United States
Suspended
Univ of Colorado Health Sciences CtrDenver, United States
Suspended
Beth Israel Deaconess - West CampusBoston, United States

Completed7 Study Centers