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Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on May 6, 2003.   Last Updated on March 13, 2010   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00059956
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Drugs used in immunotherapy such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells, and may make cancer cells more sensitive to chemotherapy. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving lower doses of radiation may cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of combining immunotherapy with combination chemotherapy followed by low-dose radiation therapy and cytarabine in treating patients who have newly diagnosed primary central nervous system lymphoma.


Condition Intervention Phase
Lymphoma
 Biological: rituximab
Drug: cytarabine
Drug: methotrexate
Drug: procarbazine hydrochloride
Drug: vincristine sulfate
Radiation: radiation therapy
 Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed PCNSL

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Vincristine Methotrexate Cytarabine hydrochloride Rituximab Cytarabine Procarbazine hydrochloride Procarbazine Vincristine sulfate
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Treatment related toxicity assessed by NCI CTC [ Designated as safety issue: Yes ]
  • Disease-free survival at 1 year [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate assessed radiographically every 2 months [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]

Study Start Date: August 2002
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of induction immunochemotherapy comprising rituximab, methotrexate, procarbazine, and vincristine followed by reduced-dose radiotherapy and consolidation cytarabine in patients with newly diagnosed primary central nervous system lymphoma.
  • Determine the 2-year and overall disease-free survival of patients treated with this regimen.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the acute treatment-related toxicity and safety of this regimen in these patients.
  • Determine the initial response rate of patients treated with immunochemotherapy.
  • Determine the relapse rate after complete response in patients treated with this regimen.
  • Determine the neuro-cognitive outcome in patients treated with this regimen.

OUTLINE: This is a multicenter, pilot study.

  • Induction immunochemotherapy: Patients receive rituximab IV over 5 hours on day 1 and methotrexate IV over 2 hours and vincristine IV over several minutes on day 2. Patients also receive oral procarbazine on days 2-8 during courses 1, 3, and 5. Treatment repeats every 2 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response after 5 courses may receive an additional 2 courses.
  • Radiotherapy: Beginning 3-5 weeks after completion of induction immunochemotherapy, patients undergo radiotherapy daily 5 days a week for 3-6 weeks.
  • Consolidation chemotherapy: Patients receive cytarabine IV over 3 hours on days 1 and 2. Treatment repeats every 28 days for a total of 2 courses.

Patients are followed every 3 months for 1 year, 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 primary non-Hodgkin's lymphoma by brain biopsy

    • Patients who have an inconclusive biopsy or who are not a candidate for biopsy are eligible provided they have a typical cranial MRI or CT scan* AND meet at least 1 of the following criteria:

      • Positive cerebrospinal fluid cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
      • Biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma NOTE: *Typical MRI or CT scan is defined as the presence of hypo-, iso-, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)
  • HIV-1 negative

  • Normal or negative pretreatment systemic evaluation including the following examinations:

    • Bone marrow aspirate and biopsy
    • CT scans of the chest, abdomen, and pelvis

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Not specified

Life expectancy

  • At least 8 weeks

Hematopoietic

  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT no greater than 2 times upper limit of normal

Renal

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 50 mL/min

Other

  • Not pregnant
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • No other active primary malignancy except basal cell skin cancer or carcinoma in situ of the cervix
  • No pre-existing immunodeficiency (e.g., renal transplantation recipient)
  • Must maintain a tyramine-free diet (i.e., free of alcohol and certain cheeses) during procarbazine administration

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for CNS lymphoma

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior cranial radiotherapy

Surgery

  • Not specified

Other

  • No citrus fruit, citrus fruit juices, or ascorbic acid supplements during and for 72 hours after methotrexate administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059956

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Kentucky
Kentuckiana Cancer Institute, PLLC
Louisville, Kentucky, United States, 40202
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, Vermont
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05401-3498
United States, Virginia
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Lauren E. Abrey, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00059956     History of Changes
Other Study ID Numbers: CDR0000298992, MSKCC-01146
Study First Received: May 6, 2003
Last Updated: March 13, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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
Cytarabine
Methotrexate
Rituximab
Procarbazine
Vincristine
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
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012



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