Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

NCT00416819 | Completed DMC

• 3 other identifiers: CDR0000458052UCSF-03301UCSF-H9414-23160-02A
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This clinical trial is studying the side effects and best ways to give combination chemotherapy together with rituximab in treating patients with newly diagnosed primary CNS lymphoma.

Conditions

Brain and Central Nervous System Tumors; Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma; primary central nervous system Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• rate of toxicity in patients with untreated primary CNS lymphoma

  Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.

  up to 8 months

Secondary Outcomes (1)

• Efficacy in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.

  up to 12 months

Study Arms (1)

methotrexate, leucovorin calcium, rituximab, and temozolomide

EXPERIMENTAL

Determine the rate of toxicity, in terms of percentage of patients with grade 4 neurotoxicity, in patients with untreated primary CNS lymphoma treated with induction therapy comprising high-dose methotrexate, leucovorin calcium, rituximab, and temozolomide followed by consolidation therapy comprising cytarabine and etoposide phosphate.

Biological: filgrastim; Biological: rituximab; Drug: cytarabine; Drug: etoposide phosphate; Drug: leucovorin calcium; Drug: methotrexate; Drug: temozolomide

Interventions

filgrastim BIOLOGICAL

methotrexate, leucovorin calcium, rituximab, and temozolomide

rituximab BIOLOGICAL

methotrexate, leucovorin calcium, rituximab, and temozolomide

cytarabine DRUG

methotrexate, leucovorin calcium, rituximab, and temozolomide

etoposide phosphate DRUG

methotrexate, leucovorin calcium, rituximab, and temozolomide

leucovorin calcium DRUG

methotrexate, leucovorin calcium, rituximab, and temozolomide

methotrexate DRUG

methotrexate, leucovorin calcium, rituximab, and temozolomide

temozolomide DRUG

methotrexate, leucovorin calcium, rituximab, and temozolomide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed untreated primary CNS lymphoma (PCNSL) confirmed by 1 of the following methods: * Brain biopsy or resection * Patients diagnosed with T-cell PCNSL allowed but will not receive rituximab on study * Cerebrospinal fluid (CSF) cytology * Positive CSF cytology with or without measurable intracranial disease * Vitreal biopsy * Histologic confirmation of vitreal lymphoma with measurable intracranial tumor * No evidence of systemic non-Hodgkin's lymphoma * CT scan of chest, abdomen, and pelvis or bone marrow biopsy negative for extracerebral source of lymphoma * No evidence of pleural effusions or ascites * MRI of brain and spine (plus gadolinium) must have measurable contrast enhancing disease unless CSF cytology is positive PATIENT CHARACTERISTICS: * Karnofsky performance score 50-100% * HIV negative * Creatinine clearance ≥ 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No concurrent salicylates, nonsteroidal anti-inflammatory drugs, sulfonamides, or penicillins within the past week

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Wieduwilt MJ, Valles F, Issa S, Behler CM, Hwang J, McDermott M, Treseler P, O'Brien J, Shuman MA, Cha S, Damon LE, Rubenstein JL. Immunochemotherapy with intensive consolidation for primary CNS lymphoma: a pilot study and prognostic assessment by diffusion-weighted MRI. Clin Cancer Res. 2012 Feb 15;18(4):1146-55. doi: 10.1158/1078-0432.CCR-11-0625. Epub 2012 Jan 6.

  PMID: 22228634 RESULT

MeSH Terms

Conditions

Central Nervous System Neoplasms; Lymphoma

Interventions

Filgrastim; Rituximab; Cytarabine; etoposide phosphate; Leucovorin; Methotrexate; Temozolomide

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Aminopterin; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles

Study Officials

• James L. Rubenstein, MD, PhD

  University of California, San Francisco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: September 1, 2003
• Primary Completion: December 1, 2005
• Study Completion: February 1, 2012
• Last Updated: August 20, 2015

Record last verified: 2015-08