Neuroendocrine Tumors
Conditions
Brief summary
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).
Interventions
50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
DRUGInterferon-alpha
3 months of treatment from the 4th cycle metronomic cyclophosphamide : subcutaneous injection, initial dose of 3 MIU three times a week. The dose may be adjusted as tolerated to achieve a T cell counts greater than 500 / mm3
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* performance status ECOG-WHO ≤ 1 * histologically proved neuroendocrine tumor with Ki67 \< or = 10%, metastatic or locally advanced without surgery possibility * at least one measurable lesion based on RECIST criteria version 1.1 * signed written informed consent
Exclusion criteria
* previous treatment with interferon or cyclophosphamide * treatment by immunosuppressive drugs * diabetes complicated by coronary artery disease or vasculopathy * severe respiratory failure, chronic respiratory failure, COPD * history of severe heart failure * severe renal or hepatic impairment * diabetes complicated with coronary artery disease or vasculopathy * alcoholism unweaned * uncontrolled epilepsy and/or achievement of the central nervous system functions * history of severe depressive syndrome * presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide * decompensated liver cirrhosis * severe myelosuppression * psoriasis and sarcoidosis * active disease condition or uncontrolled infection * association with the yellow fever vaccine * association with phenytoin in prophylaxis * hypersensitivity against interferon or cyclophosphamide * prior history of other malignancy except for: basal cell carcinoma of the skin, cervical intra-epithelial neoplasia and other cancer curatively treated with no evidence of disease for at least 3 years * pregnancy, breast-feeding or absence of adequate contraception for fertile patients * patients under guardianship, curatorship or under the protection of justice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of patients with an immune response defined as Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique | at 3 months of the association CMC and Interferon-alpha |
Countries
France
Outcome results
None listed