Methotrexate, Mannitol, Rituximab, and Carboplatin in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT00293475
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IA
  • Mannitol — DRUG
    Given IA
  • Methotrexate — DRUG
    Given IA
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Rituximab — BIOLOGICAL
    Given IV
  • Sodium Thiosulfate — DRUG
    Given IV

Study Details

This phase I/II trial studies the side effects of methotrexate, mannitol, rituximab, and carboplatin and to see how well they work in treating patients with primary central nervous system lymphoma. Drugs used in chemotherapy, such as methotrexate and carboplatin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Osmotic blood-brain barrier disruption uses mannitol to open the blood vessels around the brain and allow cancer-killing substances to be carried directly to the brain. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving methotrexate, mannitol, rituximab, and carboplatin together may be an effective treatment for primary central nervous system lymphoma.

Key Dates

Start date
Oct 14, 2005
Status verified
Sep 2021
Primary completion
Jan 31, 2022
Completion
Jan 31, 2023

Study Design

Enrollment
81 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (rituximab, mannitol, methotrexate, carboplatin)
    Patients receive rituximab IV over 5 hours on day 1, mannitol IA, methotrexate IA over 10 minutes, and carboplatin IA over 10 minutes on days 2 and 3. Patients then receive sodium thiosulfate IV over 15 minutes at 4 and 8 hours after carboplatin. Treatment repeats monthly for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of toxicities, assessed using National Cancer Institute Common Toxicity Criteria for Adverse Events version 3.0 (Phase I) [ Time Frame: Within 2 months of completion of study treatment ]

Locations (4)

FacilityCityStateZIPSite coordinators
Good Samaritan Hospital - CincinnatiCincinnatiOhio45220-
Cleveland Clinic FoundationClevelandOhio44195-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Cincinnati, OH

By research site
Good Samaritan Hospital - Cincinnati· Cincinnati, OHCleveland Clinic Foundation· Cleveland, OHOhio State University Comprehensive Cancer Center· Columbus, OHOHSU Knight Cancer Institute· Portland, OR

Related Studies