Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma
Recruitment status was Active, not recruiting
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: methotrexate Drug: zidovudine Procedure: neoadjuvant therapy Radiation: radiation therapy |
Phase 2 |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
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 |
- Efficacy [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
Estimated Enrollment: | 14 |
Study Start Date: | May 1997 |
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.
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.
PROJECTED ACCRUAL: This study will accrue 14 patients.
![](https://webarchive.library.unt.edu/web/20130228113851im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS
- No systemic lymphoma
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- WHO 0-3
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3000/mm^3
- Platelet count at least 80,000/mm^3
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
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
![](https://webarchive.library.unt.edu/web/20130228113851im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Italy | |
Centro di Riferimento Oncologico - Aviano | |
Aviano, Italy, 33081 |
Study Chair: | Umberto Tirelli, MD | Centro di Riferimento Oncologico - Aviano |
![](https://webarchive.library.unt.edu/web/20130228113851im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00003261 History of Changes |
Other Study ID Numbers: | CDR0000066153, ITA-GICAT-POS1, EU-97018 |
Study First Received: | November 1, 1999 |
Last Updated: | October 10, 2009 |
Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
AIDS-related primary CNS lymphoma |
Additional relevant MeSH terms:
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methotrexate Zidovudine Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors Reverse Transcriptase Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on February 26, 2013