Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Northwestern Memorial Hospital Columbia University
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00594815

Purpose

The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. The investigators hope that the addition of rituximab will improve the control of the tumor.

Condition	Intervention
Lymphoma	Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cytarabine Cytarabine hydrochloride Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Vincristine sulfate Vincristine Rituximab Procarbazine hydrochloride Procarbazine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

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

Primary Outcome Measures:

To determine safety and efficacy of combined immunochemotherapy followed by reduced dose radiation for patients wth newly diagnosed PCNSL. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
Acute treatment related toxicity. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
Overall 2 year disease free survival. [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Response rate to initial combined immunochemotherapy. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Relapse rate following complete response. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Overall and progression free survival. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
Neuro-cognitive outcome. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2002
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine Immunochemotherapy

Detailed Description:

The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. We hope that the addition of rituximab will improve the control of your tumor.

The second goal of this study is to assess a lower dose of brain radiation. Brain radiation may cause memory loss or dementia. For patients over the age of 60, the risk of significant memory loss is 80-90%. The risk for younger patients is smaller but less clear. In this, study patients whose tumors are in remission after chemotherapy will be treated with a lower dose of brain radiation. We hope that this lower dose will be less toxic. However, it is also possible that using a lower dose of radiation will be less effective in controlling your tumor.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients must have a histologic diagnosis of non-Hodgkin's lymphoma by brain biopsy. Patients who have an inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial magnetic resonance imaging (MRI) or computed tomography (CT) scan and meet at least one of the following two criteria:
- A positive cerebrospinal fluid (CSF) cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
- A biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma
A typical MRI/CT scan for primary intracranial lymphoma is defined as the presence of hypo, iso, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)
Patients must be HIV-1 negative
Patients must have a normal or negative pre-treatment systemic evaluation including:
- A bone marrow aspirate and biopsy
- CT scans of the chest, abdomen and pelvis
- Patients must have adequate bone marrow function (defined as peripheral leucocyte count > 4000 cells/mm3 and platelet count > 100,000 cells/mm3), liver function (bilirubin < 2.0 mg and SGOT < 2 times upper limit of normal), and adequate renal function (serum creatinine < 1.5 mg/dl or creatinine clearance > 50 cc/min/1.73M2)
Men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment

Exclusion Criteria:

The following would exclude a patient from the study:

Prior cranial irradiation
Other active primary malignancy with the exception of basal cell carcinoma of the skin and cervical carcinoma in situ
Pre-existing immunodeficiency such as renal transplant recipient
Prior treatment with chemotherapy for CNS lymphoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594815

Contacts

Contact: Lauren Abrey, MD

abreyl@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Lauren Abrey, MD abreyl@mskcc.org

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Northwestern Memorial Hospital

Columbia University

Investigators

Principal Investigator:

Lauren Abrey, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Abrey, Lauren, MD )
Study ID Numbers:	01-146
Study First Received:	January 7, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00594815
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Lymphoma
Central Nervous System

Study placed in the following topic categories:

Folic Acid
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Vincristine
Methotrexate

Leucovorin
Procarbazine
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Central nervous system lymphoma, primary

Additional relevant MeSH terms:

Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Enzyme Inhibitors
Antimitotic Agents
Reproductive Control Agents

Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Abortifacient Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009