Chemotherapy, Filgrastim, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
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|ClinicalTrials.gov Identifier: NCT00003929|
Recruitment Status : Withdrawn
First Posted : July 26, 2004
Last Update Posted : March 20, 2012
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with radiation therapy may kill more cancer cells. Colony-stimulating factors such as filgrastim allow doctors to give higher doses of chemotherapy drugs to kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of lomustine, procarbazine, filgrastim, and radiation therapy in treating patients who have primary central nervous system lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: filgrastim Drug: lomustine Drug: procarbazine hydrochloride Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine response rate, response duration, and survival of patients with AIDS-related or immunocompetent primary central nervous system lymphoma after treatment with oral lomustine and procarbazine, filgrastim (G-CSF), and radiotherapy. II. Determine toxicity of this combined modality in these patients. III. Determine quality of life of these patients.
OUTLINE: Patients are stratified by CD4 count (50/mm3 and under vs greater than 50/mm3). Patients receive oral lomustine on day 1 and oral procarbazine on days 1-10 and days 22-31. Filgrastim (G-CSF) is administered subcutaneously daily on days 12-21 and days 33-42, until absolute neutrophil counts recover. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy. Patients with a partial response, stable disease, or disease progression after 6 weeks proceed to radiotherapy without receiving a second course of chemotherapy. Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy. Quality of life is assessed prior to therapy, at 3 and 6 weeks, and then every 2 months following radiotherapy. Patients are followed every 2 months until death.
PROJECTED ACCRUAL: Approximately 16 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Modality Therapy of AIDS-Related and Immunocompetent Primary CNS Lymphoma (PCL) Using Filgrastim (G-CSF)|
|Study Start Date :||June 1998|
|Actual Primary Completion Date :||March 2000|
- Effectiveness of lomustine, procarbazine, filgrastim, and radiation therapy in treating patients who have primary central nervous system lymphoma. [ Time Frame: Patients with a CR after 6 weeks receive one additional course of chemotherapy prior to radiotherapy. Patients with a PR, stable disease, or disease progression after 6 weeks proceed to radiotherapy without receiving a second course of chemotherapy. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003929
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Scot C. Remick, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|