Chemotherapy, Filgrastim, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lymphoma
Intervention: filgrastim (Drug); lomustine (Drug); procarbazine hydrochloride (Drug); radiation therapy (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Ireland Cancer Center
Official(s) and/or principal investigator(s):
Scot C. Remick, MD, Study Chair, Affiliation: Case Comprehensive Cancer Center
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.
Official title: Combined Modality Therapy of AIDS-Related and Immunocompetent Primary CNS Lymphoma (PCL) Using Filgrastim (G-CSF)
Study design: Treatment
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
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.
Minimum age: N/A.
Maximum age: N/A.
DISEASE CHARACTERISTICS: Histologically proven AIDS-related non-Hodgkin's lymphoma of the
CNS or non AIDS-related,non-Hodgkin's lymphoma of CNS also eligible, if not eligible for
higher priority clinical trial
PATIENT CHARACTERISTICS: Age: 0-120 Performance status: ECOG 0-2 Life expectancy: At least
6 weeks Hematopoietic: WBC at least 1500/ mm3 Platelets at least 50,000/mm3 Hepatic: Serum
bilirubin no greater than 3. 0 mg/dL Renal: Serum creatinine no greater than 3. 0 mg/dL
Cardiovascular: Pulmonary: Other: Active infection(s) allowed if drug receiving treatment
No Zidovudine during combined modality chemotherapy and radition Negative CSF cytology
PRIOR CONCURRENT THERAPY: Biologic therapy: Chemotherapy: No prior chemotherapy Endocrine
therapy: Steroids may be used concurrently. Doses should be as low as possible. Increases
in steroids above study's upper limit will result in patient going off study. Radiotherapy:
No prior radiotherapy Surgery: Prior surgical debulking allowed
Locations and Contacts
Ireland Cancer Center, Cleveland, Ohio 44106-5065, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1998
Last updated: May 23, 2008