Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Newly Diagnosed Central Nervous System Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003632
First received: November 1, 1999
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with newly diagnosed CNS lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Drug: carmustine
Drug: cytarabine
Drug: etoposide
Drug: melphalan
Drug: methotrexate
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Estimated Enrollment: 30
Study Start Date: September 1998
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003632

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003632     History of Changes
Other Study ID Numbers: 98-086, MSKCC-98086, NCI-G98-1481
Study First Received: November 1, 1999
Last Updated: January 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
primary central nervous system non-Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Carmustine
Melphalan
Cytarabine
Etoposide
Methotrexate
Lenograstim
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic
Myeloablative Agonists
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 23, 2014