Clinical Trial: IL-7 in Increasing Low CD4 Counts After Concurrent Radiation and Temozolomide Treatment in Patients With High Grade Gliomas
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Effect of IL-7 (CYT107) on CD4 Counts in Patients With High Grade Gliomas and Severe Treatment-Related CD4 Lymphopenia After Concurrent Radiation and Temozolomide
Brief Summary: This pilot, partially randomized clinical trial studies how well glycosylated recombinant human interleukin-7 works in increasing low cluster of differentiation (CD)4 counts after concurrent radiation and temozolomide treatment in patients with gliomas that tend to grow rapidly and spread (high-grade). Treatment with radiation and chemotherapy, such as temozolomide, may cause an abnormal decrease in CD4 cells, which are an important part of the immune system. Glycosylated recombinant human interleukin-7 may increase CD4 cell counts and improve survival.
Detailed Summary:
PRIMARY OBJECTIVES:
I. To test the effect of CYT107 (glycosylated recombinant human interleukin-7) on CD4 counts compared to control.
SECONDARY OBJECTIVES:
I. To determine the optimal dose of CYT107. II. To evaluate the effect of concurrent dexamethasone. III. To evaluate the duration of effect on CD4 counts (up to 6 months). IV. To evaluate the total lymphocyte counts over time and serial lymphocyte subtypes (up to 6 months).
V. To evaluate the serial cytokines levels (up to 6 months). VI. To evaluate the impact of adjuvant temozolomide on CYT107 effects on CD4 counts.
VII. To evaluate anti-drug antibodies. VIII. To evaluate the safety and toxicity of CYT107 in patients with high grade glioma.
TERTIARY OBJECTIVES:
I. To explore overall survival in patients. II. Tumor infiltrative lymphocytes could be studied in patients undergoing resection of recurrent or progressive tumor.
OUTLINE: Patients are assigned to 1 of 2 groups depending on their use of dexamethasone.
GROUP A (NON-DEXAMETHASONE): Patients not on dexamethasone or on a dose lower than a physiologic dose (=< 0.75 mg daily) are randomized to 1 of 3 treatment arms.
ARM A1: Patients receive placebo intramuscularly (IM) once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.
ARM A2: Patients receive glycosylated recombinant human interleukin-7 at 10 ug/kg IM once weekly f
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome: Absolute total CD4 cell counts [ Time Frame: At 6 weeks (after standard radiation and temozolomide treatment completion) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Optimal dose of glycosylated recombinant human interleukin-7 determined by dose-limiting toxicities graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Sidney Kimmel Comprehensive Cancer Center
Dates:
Date Received: January 15, 2016
Date Started: November 2015
Date Completion: August 2018
Last Updated: December 8, 2016
Last Verified: December 2016