A Phase II Study of Intensive Methotrexate and Cytarabine Followed by High Dose Beam Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
N/A
N/A
Both
Lymphoma
Trial Information
A Phase II Study of Intensive Methotrexate and Cytarabine Followed by High Dose Beam Chemotherapy With Autologous Peripheral Blood Progenitor Cell Transplantation in Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
OBJECTIVES: I. Assess the efficacy and treatment-related toxicity of high-dose chemotherapy
comprising carmustine, etoposide, cytarabine, and melphalan followed by autologous
peripheral blood stem cell transplantation in patients with primary central nervous system
lymphoma. II. Determine the safety of this regimen in these patients. III. Determine the
efficacy of this regimen, in terms of 2-year disease-free survival, in these patients. IV.
Assess neurologic outcome using serial neurologic examinations in patients treated with this
regimen.
OUTLINE: Induction therapy: Patients receive methotrexate (MTX) IV over 2 hours once on
weeks 1, 3, 5, and 7. Patients who respond to treatment receive a fifth dose of MTX on week
9 followed by cytarabine (ARA-C) IV over 3 hours beginning 3 days after completion of MTX
infusion and continuing daily for 2 days. Filgrastim (G-CSF) is administered daily beginning
2 days after completion of ARA-C infusion and continuing until harvest of peripheral blood
stem cells (PBSC). Patients receive a second course of ARA-C IV beginning 1 month after
completion of the first course of ARA-C and continuing daily for 2 days. G-CSF is then
administered daily for about 2 weeks. High-dose chemotherapy/transplantation: Patients with
stable or responding disease after induction therapy receive high-dose carmustine IV over
1-2 hours on day -7, etoposide IV over 1 hour every 12 hours and ARA-C IV every 12 hours on
days -6 to -3, and melphalan IV on day -2. PBSC are reinfused on day 0. Patients receive
G-CSF beginning on day 1 and continuing until blood counts recover. Patients are followed
monthly for 3 months, every 3 months for 9 months, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed primary central nervous
system (CNS) lymphoma Patients who have inconclusive biopsy or who are not candidates for
biopsy may be eligible provided they have a typical cranial MRI or CT scan (presence of
hypo, iso, or hyperdense parenchymal contrast-enhancing mass lesions) to insure that
leptomeningeal nonparenchymal lymphomas are not included Must meet at least one of the
following criteria: Positive CSF cytology for lymphoma or a monoclonal lymphocyte
population as defined by cell surface markers Biopsy of the vitreous or uvea demonstrating
lymphoma Isolated CNS relapse of systemic non-Hodgkin's lymphoma allowed
PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life
expectancy: At least 8 weeks Hematopoietic: WBC at least 4,000/mm3 Platelet count at least
150,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 2 times
upper limit normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at
least 50 mL/min Cardiovascular: Ejection fraction at least 50% Pulmonary: DLCO at least
50% Other: HIV-1 negative No other active primary malignancy except basal cell skin cancer
or carcinoma in situ of the cervix No prior immunodeficiency (e.g., renal transplantation
recipient)
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for CNS lymphoma Endocrine therapy: Not specified Radiotherapy: No prior
cranial irradiation Surgery: Not specified
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Lauren E. Abrey, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
98-086
NCT ID:
NCT00003632
Start Date:
September 1998
Completion Date:
Related Keywords:
- Lymphoma
- primary central nervous system non-Hodgkin lymphoma
- Lymphoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
