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


Phase 2
N/A
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Effectiveness of lomustine, procarbazine, filgrastim, and radiation therapy in treating patients who have primary central nervous system lymphoma.

Outcome 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.

Safety Issue:

No

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU3496

NCT ID:

NCT00003929

Start Date:

June 1998

Completion Date:

Related Keywords:

  • Lymphoma
  • primary central nervous system lymphoma
  • AIDS-related primary CNS lymphoma
  • Lymphoma

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065