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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Northwestern Memorial Hospital
Columbia University
Kentuckiana Cancer Institute
University of Virginia
University of Vermont
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00594815
First received: January 7, 2008
Last updated: January 27, 2014
Last verified: January 2014
  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

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for 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:

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 ]

Enrollment: 52
Study Start Date: August 2002
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Northwestern Memorial Hospital
Columbia University
Kentuckiana Cancer Institute
University of Virginia
University of Vermont
Investigators
Principal Investigator: Antonio Omuro, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided by Memorial Sloan-Kettering Cancer Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00594815     History of Changes
Obsolete Identifiers: NCT00059956
Other Study ID Numbers: 01-146
Study First Received: January 7, 2008
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Lymphoma
Central Nervous System

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Methotrexate
Rituximab
Procarbazine
Vincristine
Leucovorin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 23, 2014