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Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer (FLUOCAR-1)

Primary Purpose

Peritoneal Carcinomatosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

SGM-101

About this trial

This is an interventional treatment trial for Peritoneal Carcinomatosis focused on measuring Peritoneal Carcinomatosis, SGM-101

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Cytologically or histologic proven primary or recurrent digestive adenocarcinoma and eligible for hyperthermic intraperitoneal chemoperfusion (HIPEC) procedure,
Evidence of peritoneal carcinomatosis, presume resectable, assessed by imaging (CT scan (Computed Tomography Scanner) and / or MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery,,
CEA positivity by immunohistochemistry on specimen of primary tumor or recurrence lesion, or circulating plasma CEA ≥ 2 times the upper limit of normal range (ULN),
ECOG (Eastern Cooperative Oncology group) < 1
Life expectancy of at least three months,
AST (Aspartate AminoTransferase), ALT (Alanine AminoTransferase) and Alkaline Phosphatase levels ≤ 5 times the ULN,
Total bilirubin ≤ 1.5 times the ULN, Serum creatinine ≤ 1.5 times the ULN, absolute neutrophils counts ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL,(red blood transfusion is allowed if needed),
Patients aged over 18 years old,
Patients affiliated to a French Social Security System,
Signed informed consent (IC) obtained before any study specific procedures.

Exclusion Criteria:

ASA (American Society of Anesthesiologists) score ≥ 3,
Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion,
Known serious immune allergic history,
Rate of circulating plasma CEA ≥ 300 ng / ml,
Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
Female patients pregnant or breastfeeding (pregnancy should be ruled by an assay of βhCG plasma within 7 days prior to administration of the conjugate). Patients with reproductive potential and who are sexually active must agree to have at least two methods of contraception for the duration of treatment (2 weeks before and 8 12 weeks after the administration of SGM-101) Male patients, must use an effective method of contraception (condom with spermicidal foam or gel; true abstinence; or vasectomy throughout the study and up to 12 weeks after last SGM-101 administration).
Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections,
Any other concurrent and/or uncontrolled medical condition or metabolic dysfunction, that would, in the investigator's judgment contraindicate her participation in the clinical study
Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Sites / Locations

Institut régional du Cancer de Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SGM-101

Arm Description

6 dose levels of SGM-101 (5mg/patient, 7.5mg/patient, 10 mg/patient, 12.5mg/patient , 15 mg/patient - 24 h prior surgery and 15 mg/patient - 48h prior surgery

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD)

Determination of the recommended phase II dose

Secondary Outcome Measures

Full Information

NCT ID

NCT02784028

First Posted

May 24, 2016

Last Updated

October 16, 2020

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

1. Study Identification

Unique Protocol Identification Number

NCT02784028

Brief Title

Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer

Acronym

FLUOCAR-1

Official Title

Phase I Study Assessing Safety of SGM-101, a Fluorochrome-labeled Anti-carcinoembryonic Antigen Monoclonal Antibody for the Detection of Neoplastic Lesions in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Completed

Study Start Date

December 2014 (Actual)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The digestive cancer is the second cause of death worldwide. The presence of peritoneal carcinomatosis is common in the evolution of this type of cancer, as well as increased levels of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low sensitivity detection means. In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as possible associated with an intraperitoneal chemotherapy gave better results but still failures associated with the presence of microscopic residual tumors. The use of SGM -101 (developped by SURGIMAB SAS) allows surgeons to detect tumor nodules of small size very easily, in real-time, during surgery (shown in animals).

Detailed Description

The digestive cancer is the second cause of death worldwide. The presence of peritoneal carcinomatosis is common in the evolution of this type of cancer, as well as increased levels of ACE. This peritoneal carcinomatosis is often underestimated, this being due to low sensitivity detection means. In recent years, it has been shown that peritoneal carcinomatosis surgery as complete as possible associated with an intraperitoneal chemotherapy gave better results but still failures associated with the presence of microscopic residual tumors. SGM -101 (developped by SURGIMAB SAS) is a fluorescent antibody that binds to ACE which is overespressed at the surface of tumor cells. The use of this fluorescent molecule allows surgeons to detect tumor nodules of small size very easily, in real-time, during surgery (shown in animals).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peritoneal Carcinomatosis

Keywords

Peritoneal Carcinomatosis, SGM-101

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SGM-101

Arm Type

Experimental

Arm Description

6 dose levels of SGM-101 (5mg/patient, 7.5mg/patient, 10 mg/patient, 12.5mg/patient , 15 mg/patient - 24 h prior surgery and 15 mg/patient - 48h prior surgery

Intervention Type

Other

Intervention Name(s)

SGM-101

Intervention Description

Administration of SGM-101 prior surgery

Primary Outcome Measure Information:

Title

Maximum tolerated dose (MTD)

Description

Determination of the recommended phase II dose

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cytologically or histologic proven primary or recurrent digestive adenocarcinoma and eligible for hyperthermic intraperitoneal chemoperfusion (HIPEC) procedure, Evidence of peritoneal carcinomatosis, presume resectable, assessed by imaging (CT scan (Computed Tomography Scanner) and / or MRI (Magnetic Resonance Imaging)) or during a previous abdominal surgery,, CEA positivity by immunohistochemistry on specimen of primary tumor or recurrence lesion, or circulating plasma CEA ≥ 2 times the upper limit of normal range (ULN), ECOG (Eastern Cooperative Oncology group) < 1 Life expectancy of at least three months, AST (Aspartate AminoTransferase), ALT (Alanine AminoTransferase) and Alkaline Phosphatase levels ≤ 5 times the ULN, Total bilirubin ≤ 1.5 times the ULN, Serum creatinine ≤ 1.5 times the ULN, absolute neutrophils counts ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L and hemoglobin ≥ 9 g/dL,(red blood transfusion is allowed if needed), Patients aged over 18 years old, Patients affiliated to a French Social Security System, Signed informed consent (IC) obtained before any study specific procedures. Exclusion Criteria: ASA (American Society of Anesthesiologists) score ≥ 3, Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion, Known serious immune allergic history, Rate of circulating plasma CEA ≥ 300 ng / ml, Other malignancies either currently active or diagnosed in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma. Female patients pregnant or breastfeeding (pregnancy should be ruled by an assay of βhCG plasma within 7 days prior to administration of the conjugate). Patients with reproductive potential and who are sexually active must agree to have at least two methods of contraception for the duration of treatment (2 weeks before and 8 12 weeks after the administration of SGM-101) Male patients, must use an effective method of contraception (condom with spermicidal foam or gel; true abstinence; or vasectomy throughout the study and up to 12 weeks after last SGM-101 administration). Known positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C virus (HCV) antibody or patients with untreated serious infections, Any other concurrent and/or uncontrolled medical condition or metabolic dysfunction, that would, in the investigator's judgment contraindicate her participation in the clinical study Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Francois Quenet

Organizational Affiliation

Institut régional du Cancer de Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

Institut régional du Cancer de Montpellier

City

Montpellier

ZIP/Postal Code

34298

Country

France

12. IPD Sharing Statement

Plan to Share IPD

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Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer

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