Study of High-Dose Rituximab With Temozolomide as Treatment for Primary Central Nervous System (CNS) Lymphoma

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT02113007
Phase
PHASE2
Status
Terminated

Conditions

  • Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab plus Temozolomide — DRUG
    Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.

Study Details

This study will evaluate the safety and efficacy of high-dose rituximab combined with temozolomide in the treatment of patients with Primary Central Nervous System Lymphomas (PCNSL). This novel combination will be evaluated in PCNSL patients who are 60 years of age or older, or in patients 18 years or older who refuse methotrexate-based treatment.

Key Dates

Start date
Jul 31, 2014
Status verified
Dec 2016
Primary completion
Feb 29, 2016
Completion
Feb 29, 2016

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab plus Temozolomide
    Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5

Primary Outcome Measure

Overall Response Rate [ Time Frame: approximately 32 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520-
Memorial Cancer InstituteHollywoodFlorida33021-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Tennessee Oncology PLLCNashvilleTennessee37203-

Find similar trials in New Haven, CT

By research site
Yale School of Medicine· New Haven, CTMemorial Cancer Institute· Hollywood, FLFlorida Hospital Cancer Institute· Orlando, FLTennessee Oncology PLLC· Nashville, TN

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