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Chemotherapy, Filgrastim, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma
This study is ongoing, but not recruiting participants.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003929
  Purpose

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 Intervention Phase
Lymphoma
Biological: filgrastim
Drug: lomustine
Drug: procarbazine hydrochloride
Radiation: radiation therapy
Phase II

MedlinePlus related topics: Cancer Lymphoma Radiation Therapy
Drug Information available for: Lomustine Filgrastim Procarbazine hydrochloride Procarbazine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Combined Modality Therapy of AIDS-Related and Immunocompetent Primary CNS Lymphoma (PCL) Using Filgrastim (G-CSF)

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 16
Study Start Date: June 1998
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003929

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Scot C. Remick, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067118, CWRU-3496, CWRU-AMC-2A-93, NCI-G99-1533
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003929     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
primary central nervous system lymphoma
AIDS-related primary CNS lymphoma

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lomustine
Central Nervous System Lymphoma, Primary
Procarbazine
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Procarbazine
Lymphoproliferative Disorders
Lymphoma
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009