Status:
TERMINATED
Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer
Lead Sponsor:
Nantes University Hospital
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Phase I/II, Open-labeled, Prospective, Multi-center study of a Pretargeted Radioimmunotherapy in metastatic colorectal cancer with ractionated injections of TF2 plus 90Y-IMP288 (RITCOLON).
Detailed Description
This study investigates a pretargeted radioimmunotherapy (pRAIT) with the anti-carcinoembryonic antigen (CEA) TF2 bispecific monoclonal antibody (BsMAb) and the 90Y-IMP288 radio-labeled peptide. TF2 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Metastatic colorectal cancer and failure to standard therapies (5-fluorouracil, irinotecan, oxaliplatin, anti-vascular endothelium growth factor, anti-epidermal growth factors in patients with RAS wild type tumors). A previous line with regorafenib is not required.
- Elevated CEA serum level or proved CEA expression in tumor tissue
- ≥ 18 years of age,
- Given signed, written informed consent
- Existence of at least one measurable tumor lesion by CT or MRI at the time of treatment, but no single lesion ≥ 8 cm in diameter.
- At least 4 weeks recovery period after any major surgery, radiation, or chemotherapy, and total recovery from any acute toxicities associated with these prior treatments.
- Life expectancy ≥ 3 months, Karnofsky performance status of ≥ 70%
- Adequate hematology and renal function and hepatic function
- Patients of childbearing potential must be willing to practice birth control during the study until at least 12 weeks after treatment, and women of childbearing potential must have a negative serum pregnancy test to enter the study
- Exclusion Criteria :
- Known central nervous system metastatic disease
- \> 25% bone marrow involvement
- CEA plasma levels \>2,000 ng/mL
- Patients with successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
- HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients
- Known autoimmune disease,
- Known history of unstable angina, myocardial infarction, or congestive heart failure present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy, no known history of clinical significant, active chronic obstructive pulmonary disease, or other moderate to severe chronic respiratory illness present within 6 months
- Infection requiring intravenous antibiotic use within 1 week before inclusion,
- Corticosteroids are not allowed within 2 weeks of study entry nor during the study except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis.
- Patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.
- Known hypersensitivity to murine antibodies or proteins
- Immunization against TF2 for patients who has already received injection of TF2
- Adult patient unable to give informed consent because of intellectual impairment.
- Adult patient protected by the French law
- \-
Exclusion
Key Trial Info
Start Date :
January 27 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT02300922
Start Date
January 27 2015
End Date
December 20 2017
Last Update
August 1 2022
Active Locations (1)
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1
CHU de Nantes
Nantes, France, 44093