Neuroendocrine TumorsPhase 2EPICentroNCT02838342
Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
A Phase 2 study testing Metronomic cyclophosphamide and Interferon-alpha in people with Neuroendocrine Tumors, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial summary
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- Metronomic cyclophosphamide and Interferon-alpha
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesFrance
- Study dates
- 19 May 2015to 29 Jun 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Besançon
Besançon
Hôpital Nord Franche-Comté
Montbéliard
About this study
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).
- Conditions
- Neuroendocrine Tumors
- Being tested
- Metronomic cyclophosphamide, Interferon-alpha
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronomic cyclophosphamideDrug
Also called CMC
50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
Interferon-alphaDrug
Also called IFN-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
| Study group | Role | What they receive |
|---|---|---|
| Metronomic cyclophosphamide and interferon-alpha | Experimental | Not described Receives: Drug: Metronomic cyclophosphamide; Drug: Interferon-alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
Measured: at 3 months of the association CMC and Interferon-alpha
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start19 May 2015
- Primary completionApr 2020
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838342
- Sponsor's protocol ID
- API/2015/61
- Acronym
- EPICentro
- Status last verified
- Jul 2021
- First submitted
- 18 Jul 2016
- Last updated
- 2 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaco-immunological Study of Interferon-alpha and Metronomic Cyclophosphamide Association in Neuroendocrine Tumors
- ClinicalTrials.gov ID
- NCT02838342
- Acronym / sponsor ID
- EPICentro / API/2015/61
- Conditions
- Neuroendocrine Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 19 May 2015 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the potential immunomodulatory synergy of the association of metronomic cyclophosphamide (CMC) and interferon-alpha (IFN-alpha).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metronomic cyclophosphamide and interferon-alpha | Experimental | Drug: Metronomic cyclophosphamide, Drug: Interferon-alpha |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronomic cyclophosphamideAlso: CMC50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance | Drug | Metronomic cyclophosphamide and interferon-alpha |
| Interferon-alphaAlso: IFN-alpha3 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 | Drug | Metronomic cyclophosphamide and interferon-alpha |
Primary outcome
rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique"
Time frame: at 3 months of the association CMC and Interferon-alpha
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metronomic cyclophosphamide and Interferon-alpha in people with Neuroendocrine Tumors, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of patients with an immune response defined as "Tregs lymphocytes decrease ≥ 20% in blood by the flow cytometry technique" (time frame: at 3 months of the association CMC and Interferon-alpha). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021.