Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors

• Status: Completed
• Trial end date: 2021-06-29
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Treatments: Cyclophosphamide; Interferon-alpha; Interferons

Criteria

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