Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 18 and over | Other | ITA-GICAT-POS1 EU-97018, NCT00003261 |
Objectives
- Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients.
- Evaluate the toxicity and overall survival of these patients.
Entry Criteria
Disease Characteristics:
- Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS
- No systemic lymphoma
Prior/Concurrent Therapy:
- No prior chemotherapy or radiotherapy
Patient Characteristics:
Age:
- 18 and over
Performance status:
- WHO 0-3
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3000/mm3
- Platelet count at least 80,000/mm3
Hepatic:
- No serious impairment of liver function
Renal:
- No serious impairment of renal function
- Creatinine clearance at least 40 mL/min
Cardiovascular:
- No serious impairment of cardiac function
Neurologic:
- Neurological functional status 0-3
Other:
- No prior or active CNS-opportunistic infections
- No AIDS dementia complex
- No active systemic infections
Expected Enrollment
14This study will accrue 14 patients.
Outcomes
Primary Outcome(s)Efficacy
Toxicity
Overall survival
Outline
Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks. Patients receive 3 courses of therapy. Following chemotherapy, patients receive radiation therapy to the lesion site daily.
Patients are followed every 3 months for 1 year and then every 6 months thereafter.
Trial Lead Organizations
Centro di Riferimento Oncologico - Aviano
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| Umberto Tirelli, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Treatment of HIV-Related Primary Central Nervous System Lymphoma (HIV-PCNSL): A Phase II Trial With Neoadjuvant Chemotherapy (High-Dose Methotrexate (MTX) Plus High-Dose Zidovudine) and Radiotherapy | |
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| Trial Start Date | 1997-05-01 | |
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| Registered in ClinicalTrials.gov | NCT00003261 | |
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| Date Submitted to PDQ | 1997-12-09 | |
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| Information Last Verified | 2001-10-09 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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