Last updated on March 2019

IL-7 in Increasing Low CD4 Counts After Concurrent Radiation and Temozolomide Treatment in Patients With High Grade Gliomas


Brief description of study

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 Study Description

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 for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM A3: Patients receive glycosylated recombinant human interleukin-7 at 20 ug/kg IM once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. GROUP B (DEXAMETHASONE): Patients requiring dexamethasone at more than a physiologic dose (> 0.75 mg daily) are randomized to 1 of 2 treatment arms. ARM B1: Patients receive glycosylated recombinant human interleukin-7 as in Arm A2. ARM B2: Patients receive glycosylated recombinant human interleukin-7 as in Arm A3. In all arms, patients receive adjuvant temozolomide on days 1-5 as per standard treatment beginning 2 weeks post-glycosylated recombinant human interleukin-7 treatment. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. 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 for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. ARM A3: Patients receive glycosylated recombinant human interleukin-7 at 20 ug/kg IM once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. GROUP B (DEXAMETHASONE): Patients requiring dexamethasone at more than a physiologic dose (> 0.75 mg daily) are randomized to 1 of 2 treatment arms. ARM B1: Patients receive glycosylated recombinant human interleukin-7 as in Arm A2. ARM B2: Patients receive glycosylated recombinant human interleukin-7 as in Arm A3. In all arms, patients receive adjuvant temozolomide on days 1-5 as per standard treatment beginning 2 weeks post-glycosylated recombinant human interleukin-7 treatment. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2 months for 2 years and then every 6 months thereafter.

Clinical Study Identifier: NCT02659800

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UCSF Comprehensive Cancer Center

San Francisco, CA United States
1.16miles
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Recruitment Status: Open


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