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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02784028
Recruitment Status : Completed
First Posted : May 26, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Study Description
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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).


Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Other: SGM-101 Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 8, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: SGM-101
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
 Other: SGM-101
Administration of SGM-101 prior surgery


Outcome Measures
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Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: 18 months ]
    Determination of the recommended phase II dose


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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).
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784028


Locations
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France
Institut régional du Cancer de Montpellier
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
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Principal Investigator: Francois Quenet Institut régional du Cancer de Montpellier
More Information
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Responsible Party: Institut du Cancer de Montpellier - Val d'Aurelle
ClinicalTrials.gov Identifier: NCT02784028    
Other Study ID Numbers: ICM-URC-2014/35
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: October 20, 2020
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut du Cancer de Montpellier - Val d'Aurelle:
Peritoneal Carcinomatosis
SGM-101
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases