Clinical trial · Interventional
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
NCT02838342CI-TRIAL-00053014EPICentrocompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon-alpha | Drug | — | UNRESOLVED |
| Metronomic cyclophosphamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metronomic cyclophosphamide and interferon-alpha
- interventionNames
- Drug: Metronomic cyclophosphamide
- Drug: Interferon-alpha
Primary outcomes (1)
- measure
- rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
- timeFrame
- at 3 months of the association CMC and Interferon-alpha
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.