Phase II Trial of Sequential Chemotherapy and Radiotherapy for AIDS-Related Primary Central Nervous System Lymphoma
2 other identifiers
interventional
33
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
April 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2012
October 1, 2012
November 2, 1999
October 31, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
ECOG Data Management Office
Brookline, Massachusetts, 02146, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Related 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. doi: 10.1200/JCO.1996.14.2.556.
PMID: 8636771BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Krigel RL
- STUDY CHAIR
Von Roenn J
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
April 1, 1998
Last Updated
November 1, 2012
Record last verified: 2012-10