Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer

Peritoneal Carcinomatosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784028
• Other study ID #: ICM-URC-2014/35
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: December 8, 2017

Study information

• Verified date: May 2016
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 8, 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cytologically or histologic proven primary or recurrent digestive adenocarcinoma and eligible for hyperthermic intraperitoneal chemoperfusion (HIPEC) procedure,

2. 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,,

3. 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),

4. ECOG (Eastern Cooperative Oncology group) < 1

5. Life expectancy of at least three months,

6. AST (Aspartate AminoTransferase), ALT (Alanine AminoTransferase) and Alkaline Phosphatase levels = 5 times the ULN,

7. 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),

8. Patients aged over 18 years old,

9. Patients affiliated to a French Social Security System,

10. Signed informed consent (IC) obtained before any study specific procedures.

Exclusion Criteria:

1. ASA (American Society of Anesthesiologists) score = 3,

2. Anticancer therapy (e.g. chemotherapy, radiotherapy, targeted therapy, concomitant systemic immune therapy, or any experimental therapy) within 4 weeks before inclusion,

3. Known serious immune allergic history,

4. Rate of circulating plasma CEA = 300 ng / ml,

5. 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.

6. Female patients pregnant or breastfeeding (pregnancy should be ruled by an assay of ßhCG 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).

7. 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,

8. 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

9. Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study.

Related Conditions & MeSH terms

• Carcinoma
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

Intervention

Other:
• SGM-101
Administration of SGM-101 prior surgery

Locations

Country	Name	City	State
France	Institut régional du Cancer de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD)	Determination of the recommended phase II dose	18 months