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Trial record 4 of 4 for:    SGM-101

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 : Unknown
Verified May 2016 by Institut du Cancer de Montpellier - Val d'Aurelle.
Recruitment status was:  Recruiting
First Posted : May 26, 2016
Last Update Posted : August 14, 2017
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Tracking Information
First Submitted Date  ICMJE May 24, 2016
First Posted Date  ICMJE May 26, 2016
Last Update Posted Date August 14, 2017
Actual Study Start Date  ICMJE December 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2016)
Maximum tolerated dose (MTD) [ Time Frame: 18 months ]
Determination of the recommended phase II dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study in Patients With Peritoneal Carcinomatosis From CEA Overexpressing Digestive Cancer
Official Title  ICMJE 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
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peritoneal Carcinomatosis
Intervention  ICMJE Other: SGM-101
Administration of SGM-101 prior surgery
Study Arms  ICMJE 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
Intervention: Other: SGM-101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 25, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02784028
Other Study ID Numbers  ICMJE ICM-URC-2014/35
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francois Quenet Institut régional du Cancer de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP