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Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma



Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

For Condition: AIDS-related primary CNS lymphoma
Status: Recruiting
Sponsor(s): Centro di Riferimento Oncologico - Aviano ,
Synopsis: 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: Phase II trial to study the effectiveness of methotrexate and zidovudine combined with radiation therapy in treating patients with HIV-related primary central nervous system lymphoma.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
UmbertoTirelli,  Study Chair,  Centro di Riferimento Oncologico - Aviano

Centro di Riferimento Oncologico - Aviano *Recruiting*
Aviano,  ,  33081
Italy
Recruiting Umberto  Tirelli 39-043-465-9284


Additional Information:
Study ID Numbers:
  CDR0000066153;  ITA-GICAT-POS1,EU-97018
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003261

Other Aids-Related Primary Cns Lymphoma Studies:
1. Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma

2. Zidovudine Plus Interleukin-2 and Ganciclovir in Treating Patients With AIDS-Related Primary Central Nervous System Lymphoma

3. Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

4. Hydroxyurea in Treating Patients With Epstein-Barr Virus-Associated Primary CNS Lymphoma and AIDS

Related Studies:

Other AIDS-related primary CNS lymphoma Clinical Trials
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Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

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