Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-11-01
33
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
Trial Site Locations
How is the study designed?
Frequently Asked Questions
Research Publications
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
Who Can Participate
Age: 16Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 7 locations
1
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
2
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
3
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
4
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States, 02215
Status Unknown
5
ECOG Data Management Office
Brookline, Massachusetts, United States, 02146
Status Unknown
6
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
7
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Preirradiation chemotherapy with cyclophosphamide, doxorubicin, vincristine, and dexamethasone for primary CNS lymphomas: initial report of radiation therapy oncology group protocol 88-06.