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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study of High-Dose Rituximab Combined With Temozolomide as Treatment for Patients With Primary CNS Lymphoma

Brief Summary: 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.

Detailed Summary: This is a Phase II, multi-centered, single-arm study. A brief patient lead-in portion will be included to assess safety and feasibility. The first six patients enrolled will be monitored weekly for safety during two treatment cycles (4 weeks) for adverse events to assure there are no unexpected or prohibitive toxicities. If safety signals emerge from this group of patients, the protocol may be discontinued or modified.
Sponsor: SCRI Development Innovations, LLC

Current Primary Outcome: Overall Response Rate [ Time Frame: approximately 32 weeks ]

Patients will be assessed for response by MRI of brain and/or spine after 4 cycles (8 weeks) of treatment according to Response Criteria for Primary CNS Lymphoma. Patients with stable disease or better (CR or PR) will continue treatment for 12 cycles (24 weeks). Complete Response (CR)=no contrast enhancement, normal eye exam. Partial Response (PR)=50 percent decrease in tumor enhancement, minor retinal pigment epithelium abnormality in eye exam. Stable disease (SD)= a change in lesion size that is neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for progressive disease.


Original Primary Outcome: Overall Response Rate (ORR) [ Time Frame: up to 36 weeks ]

Determine the overall response rate (ORR) of patients with primary central nervous system lymphoma (PCNSL) when treated with high-dose rituximab combined with temozolomide.


Current Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: 6 and 12 months ]
    Six and twelve-month CNS progression-free survival rate.
  • Number of Participants With Serious and Non-serious Adverse Events as a Measure of Safety. [ Time Frame: up to 4 weeks ]
    Patients in the safety lead-in part of the study were monitored for up to 2 treatment cycles (4 weeks) to assure there were no unexpected or prohibitive toxicities. A non-serious adverse event is any untoward medical occurrence. A serious adverse event (SAE) is an event that meets one or more of the following: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; requires intervention to prevent permanent impairment or damage. Specific AE and SAE terms are provided in the Adverse event module.


Original Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: 6 and 12 months ]
    Six and twelve-month CNS progression-free survival rate.
  • Number of Participants with Serious and Non-serious Adverse Events [ Time Frame: up to 4 weeks ]
    Evaluate toxicity of the high-dose rituximab/temozolomide combination.


Information By: SCRI Development Innovations, LLC

Dates:
Date Received: April 10, 2014
Date Started: July 2014
Date Completion:
Last Updated: December 14, 2016
Last Verified: December 2016