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Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00335140
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.


Condition Intervention Phase
Lymphoma
Drug: cytarabine
Drug: dexamethasone
Drug: leucovorin calcium
Drug: methotrexate
Drug: procarbazine hydrochloride
Drug: rituximab
Drug: vincristine sulfate
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Cytarabine Cytarabine hydrochloride Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Methotrexate Vincristine sulfate Vincristine Rituximab Calcium gluconate Procarbazine hydrochloride Procarbazine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma

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

Primary Outcome Measures:
  • Complete response rate at the end of study treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Proportion progression free [ Designated as safety issue: No ]
  • Survival [ Designated as safety issue: No ]

Estimated Enrollment: 43
Study Start Date: December 2006
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the complete response rate.

Secondary

  • Determine the progression-free survival of these patients.
  • Determine the proportion of progression-free and overall survival in these patients.
  • Determine rituximab cerebrospinal fluid pharmacokinetics (only in patients requiring intrathecal chemotherapy).

OUTLINE: This is a multicenter study.

Patients receive rituximab IV 3 times weekly in weeks 1-4; high-dose methotrexate IV over 2 hours in weeks 1, 3, 5, and 9; oral or IV leucovorin calcium every 6 hours for 12 doses beginning 24 hours after the start of methotrexate in weeks 1, 3, 5, and 9; vincristine IV in weeks 1, 3, 5, 7, and 9; oral procarbazine hydrochloride daily on days 1-7 in weeks 1, 5, and 9; oral dexamethasone daily in weeks 1-6; and cytarabine IV over 2 hours twice weekly in weeks 11 and 14.

Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of methotrexate in weeks 2, 4, 6, 8, and 10.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-Hodgkin's lymphoma by brain biopsy
  • Patients with inconclusive biopsy or patients who are not candidates for biopsy must have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria:

    • Positive cerebrospinal fluid cytology for lymphoma OR a monoclonal lymphoid population as defined by cell surface markers or immunoglobulin gene rearrangement studies
    • Biopsy-proven involvement of the vitreous or uvea if cells are apparent in the posterior chamber or vitreous by ophthalmological examination
  • Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by pretreatment MRI/CT scan

    • Meningeal or vitreous involvement constitutes evaluable but not measurable disease
    • If an excisional, rather than a needle biopsy was done, measurable disease must be present on a postoperative scan
    • PET-CT scan not allowed
  • No systemic lymphoma (as determined by pre-registration CT scans and physical examination)

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-3
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Bilirubin ≤ upper limit of normal (ULN)
  • SGOT ≤ 2.0 times ULN
  • Creatinine clearance ≥ 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No HIV-1 positivity
  • No other malignancy within the past 5 years except basal cell skin cancer or any carcinoma in situ
  • No pre-existing immunodeficiency
  • No hepatitis B surface antigen positivity

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy or radiotherapy for primary central nervous system lymphoma
  • No prior organ or bone marrow transplantation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335140

  Show 91 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Lode J. Swinnen, MD Sidney Kimmel Comprehensive Cancer Center
Investigator: Deborah T. Blumenthal, MD University of Utah
  More Information

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

Study ID Numbers: CDR0000475776, ECOG-E1F05
Study First Received: June 7, 2006
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00335140  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
primary central nervous system lymphoma

Study placed in the following topic categories:
Dexamethasone
Immunoproliferative Disorders
Rituximab
Leucovorin
Vincristine
Central nervous system lymphoma, primary
Folic Acid
Calcium, Dietary
Lymphatic Diseases
Methotrexate
Procarbazine
Lymphoproliferative Disorders
Lymphoma
Cytarabine
Dexamethasone acetate

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Vitamins
Therapeutic Uses
Abortifacient Agents
Micronutrients
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Vitamin B Complex
Immune System Diseases
Antineoplastic Agents, Hormonal
Growth Substances
Mitosis Modulators
Gastrointestinal Agents
Enzyme Inhibitors
Antimitotic Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents

ClinicalTrials.gov processed this record on January 16, 2009