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) ]

The primary treatment effect is defined as an absolute increase in CD4 counts in patients treated with glycosylated recombinant human interleukin-7 compared to the control group patients without glycosylated recombinant human interleukin-7 at week 6 after radiation treatment + temozolomide treatment.


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 ]

The optimal dose will be selected based on the highest absolute increase of CD4 counts compared to the control if toxicity profiles are similar between the two dose levels. Otherwise, safety will be the first consideration for dose selection. The results of the two concurrent dexamethasone groups will be summarized with standard descriptive statistics. The dose selection criteria will be similar to the non-dexamethasone groups with priority on safety rather than the highest absolute increase of CD4 counts.


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