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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003929
• Other study ID #: CWRU3496
• Secondary ID: P30CA043703CWRU-
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: March 16, 2012
• Start date: June 1998

Study information

• Verified date: March 2012
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• filgrastim
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.

Drug:
• lomustine
Oral lomustine on day 1. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.
• procarbazine hydrochloride
Oral procarbazine on days 1-10 and days 22-31. Patients with a complete response after 6 weeks receive one additional course of chemotherapy prior to radiotherapy.

Radiation:
• radiation therapy
Whole brain radiotherapy is administered daily for 28 days beginning 1-3 weeks following chemotherapy.

Locations

Country	Name	City	State
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness of lomustine, procarbazine, filgrastim, and radiation therapy in treating patients who have primary central nervous system lymphoma.		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.	No