NCT01368107

Study Evaluating Impact of IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

A Randomised, Multicentric, Phase 2a Study Evaluating the Impact of an Immunotherapy by IL-7 on CD4 Lymphopenia, Risks of Severe Haematological Toxicity and Tumor Progression in Metastatic Breast Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the impact of an immunotherapy by IL-7 on CD4 lymphopenia, risks of severe haematological toxicity and tumor progression in metastatic breast cancer patients. The primary objective is to determine the optimal schedule to deliver CYT107 during chemotherapy based on restoration of CD4 count. This study is a phase II, randomised, double-blind, placebo-controlled, single-centre. 24 patients will be included in the study.

Detailed description

A key secondary objective is to determine if CYT107 treatment enables to reduce the incidence of severe haematological toxicity (any type of haematological toxicity Grade ≥ 3) post-chemotherapy. Other secondary objectives are to assess the impact of CYT107 treatment on the following parameters: * Overall incidence of side effects (any type any grade) * Progression-free survival (PFS) * Compliance to chemotherapy regimen (dose intensity, number of chemotherapy cycles). * CD4 lymphopenia over the study period Exploratory biological markers A series of biomarkers analyses will be performed to evaluate if CYT107 treatment will: * selectively stimulate the proliferation and activation of peripheral immune subsets (analysis of phenotype and activation status of peripheral immune e sub-populations) * selectively improve the functional response of T cells, DC subsets and NK cells. * is able to revert tolerogenic immune burden to increase specific anti-tumor response (measure of antigen specific CD8 response, measure of cytokine plasmatic levels) * enable to increase TCR diversity (analysis of combinatorial diversity).

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	placebo	Placebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)
DRUG	interleukin 7	patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and the placebo during the 3rd CT cycle (D57, D64, D71)
DRUG	interleukin 7	patients will receive the placebo before the 1st CT cycle (D0, D7, D14) and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)
DRUG	interleukin 7	patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-09-01
• Completion: 2014-06-01
• First posted: 2011-06-07
• Last updated: 2015-02-09

Locations

3 sites across 1 country: France