Chemotherapy, Filgrastim, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

March 16, 2012 updated by: Case Comprehensive Cancer Center

Combined Modality Therapy of AIDS-Related and Immunocompetent Primary CNS Lymphoma (PCL) Using Filgrastim (G-CSF)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (ACTUAL)

March 1, 2000

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

July 23, 2004

First Posted (ESTIMATE)

July 26, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CWRU3496
  • P30CA043703 (U.S. NIH Grant/Contract)
  • CWRU-3496 (OTHER: Case Comprehensive Cancer Center)
  • CWRU-AMC-2A-93
  • NCI-G99-1533

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoma

Clinical Trials on filgrastim

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe