Status:
COMPLETED
T Regulatory Lymphocytes (Treg) Depletion for Cancer Treatment Efficacy and Safety Study
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
T regulatory lymphocytes were shown to be partly responsible for immune tolerance to cancer cells. In that respect these cells oppose to the mounting of an efficacious immune response needed to cure c...
Detailed Description
The primary goal of the proposed clinical trial is to eliminate cancer tumor using an autologous cell therapy aiming at mounting an efficient immune anti-tumor response by selectively depleting regula...
Eligibility Criteria
Inclusion
- Colon or rectal adenocarcinoma histologically proven;
- Hepatic or lung metastasis (at least one with size \>1cm on CT-scan);
- Not eligible for surgery;
- Prior treatment with fluoropyrimidines, CPT11, oxaliplatine and EGFR antibodies (Cetuximab ou Panitumumab) ± bevacizumab; When tumor has a mutated Kras, prior treatment with EGFR antibodies is not mandatory;
- No local recurrence (on CT-scan, sonogram and/or colonoscopy);
- Karnofsky index \> 70 and PS 0 or 1;
- ASA Score \< 3 ;
- Absence of chronic hepatopathy ;
- Lab test : WBC: neutrophil\> 2.0 109 / l, lymphocytes \> 1.5 109 / l; creatinine \< 1.5 x ULN or clearance ≥ 60 ml/min; AST et ALT\< 5 x ULN, alkaline phosphatases \< 3 x ULN; LDH \< 3 x ULN; negative Coombs test ;
- Signed informed consent.
Exclusion
- Peritoneal carcinosis on CT-scan, MRI or PET-scan;
- Contra-indication to MRI;
- Patient with known allergy to iodinated contrast agent, gadolinium or Sulfate Hexafluoron ;
- Presence of metastasis at sites other than lung and liver;
- Documented history of auto-immune disease and/ or progressing disease;
- Infection at whatever site;
- Documented history of allo- or autograft;
- Undernutrition, BMI \< 18;
- History of other cancer \< 5 years (excluding cancer in situ of the cervix and baso-cellular tumor of the skin) or progressing disease;
- Women of child bearing age without contraception , or pregnant or breast feeding.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00986518
Start Date
October 1 2012
End Date
February 1 2013
Last Update
November 25 2013
Active Locations (1)
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1
Service hépato-gastro-enterologie, Pitié-Salpêtrière Hospital
Paris, France, 75013