EPICentro: Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
Study Details
Study Description
Brief Summary
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Metronomic cyclophosphamide and interferon-alpha
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Drug: Metronomic cyclophosphamide
50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
Other Names:
Drug: Interferon-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
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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performance status ECOG-WHO ≤ 1
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histologically proved neuroendocrine tumor with Ki67 < or = 10%, metastatic or locally advanced without surgery possibility
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at least one measurable lesion based on RECIST criteria version 1.1
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signed written informed consent
Exclusion Criteria:
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previous treatment with interferon or cyclophosphamide
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treatment by immunosuppressive drugs
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diabetes complicated by coronary artery disease or vasculopathy
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severe respiratory failure, chronic respiratory failure, COPD
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history of severe heart failure
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severe renal or hepatic impairment
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diabetes complicated with coronary artery disease or vasculopathy
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alcoholism unweaned
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uncontrolled epilepsy and/or achievement of the central nervous system functions
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history of severe depressive syndrome
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presence or history of severe psychiatric condition, particularly severe depression, suicidal thoughts or attempted suicide
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decompensated liver cirrhosis
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severe myelosuppression
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psoriasis and sarcoidosis
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active disease condition or uncontrolled infection
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association with the yellow fever vaccine
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association with phenytoin in prophylaxis
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hypersensitivity against interferon or cyclophosphamide
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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
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pregnancy, breast-feeding or absence of adequate contraception for fertile patients
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patients under guardianship, curatorship or under the protection of justice
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Centre Hospitalier Universitaire de Besançon | Besancon | France | ||
2 | Hôpital Nord Franche-Comté | Montbéliard | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- API/2015/61