Overview

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

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Leon Berard
Collaborators:
Cytheris, Inc.
Ministry of Health, France
Criteria
Inclusion Criteria:

- Female aged more than 18 years

- Histologic diagnosis of metastatic breast cancer to be treated with capecitabine at
study entry. NB: Patients previously treated with capecitabine are eligible only if
more than 6 months have elapsed since the last capecitabine intake.

- Lymphopenic (i.e. with at least one value of lymphocyte count 1500/µL within 15 days
before Day 0).

- Performance status ECOG of 0, 1,2 or 3

- Life expectancy ≥ 6months

- Adequate bone marrow, hepatic and renal function as follows:

- Neutrophils ≥ 1,000/µL

- Platelets ≥ 100 109/µL

- ASAT, ALAT, or Alkaline Phosphatase ≤ 2.5 x ULN

- Total Bilirubin ≤ 1.5 x ULN

- INR ≤ 1.5

- Calculated creatinin clearance ≥ 60mL/min (Cockcroft formula or MDRD formula for
patients older than 65 years old)- Ability to understand and sign informed
consent

- Covered by a medical insurance.

Exclusion Criteria:

- Prior history of other malignancies other than breast cancer (except for basal cell or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the
subjects has been free of the disease for at least 3 years.

- No resolution of specific toxicities related to any prior anti-cancer therapy to Grade
≤2 according to the NCI CTCAE v.4.0 (except lymphopenia, alopecia and neuropathy)

- Wash out period of less than 5 times the half-life of previous anti-cancer treatment
before study entry, except if previous chemotherapy treatment before study entry. NB:
For patient previously treated by hormonotherapy, a wash out period of 1 week will be
sufficient

- Uncontrolled hypertension (i.e., resting systolic blood pressure greater than140 mmHg
or resting diastolic blood pressure greater than 90 mmHg), despite pharmacologic
antihypertensive treatment, confirmed with a second blood pressure measurement done
later in the same day

- History of lymphoid malignancy (e.g. Hodgkin disease, non Hodgkin lymphoma, Leukemia).

- History of splenectomy or hematologic disease associated with hypersplenism, such as
gamma or beta-thalassemia, hereditary spherocytosis, Gaucher's disease, or autoimmune
hemolytic anemia.

- Any cardiac, pulmonary, thyroid, renal, hepatic, neurological severe/uncontrolled
concurrent medical disease that in the opinion of the investigator could cause
unacceptable safety risks or compromise compliance with the protocol

- Any history of severe auto-immune disease

- Hepatitis B antigen (HBs Ag) positive, Hepatitis C (HCV Ab) antibody positive or HCV
RNA detectable

- Documented HIV-1 positivity

- History of cardiovascular disorders grade >2 (NYHA) within 6 months preceding the
inclusion

- Active uncontrolled viral, fungal or bacterial infection

- Active drug or alcohol use or dependence that, in the opinion of the investigator,
would interfere with adherence to study requirements (participants must agree to
refrain from substance abuse use during the entire course of the study)

- Pregnant or breast-feeding women

- No use of effective birth control methods for women of childbearing potential

- Any contraindications to capecitabine treatment (refer to Xeloda SPC Appendix 11) and
to any other anti-cancer treatment authorized as per protocol (refer to respective SPC
for specific contraindications)