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Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer (RITCOLON)

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ClinicalTrials.gov Identifier: NCT02300922
Recruitment Status : Unknown
Verified January 2017 by Nantes University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2014
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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).

Condition or disease Intervention/treatment Phase
Metastatic Colorectal Cancer Drug: Antibody TF2 Drug: 90-Y-IMP-288 Drug: 111-In-IMP-288 Phase 1 Phase 2

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 will be given once a week for 3 successive weeks at 75 mg/m2 per dose. IMP288 will be given 3 times, 1 day after each TF2 injection. IMP288 will be radio-labeled with 111In (imaging) for the first injection and then 90Y (therapy) for the 2 subsequent injections.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Pretargeted Radioimmunotherapy in Metastatic Colorectal Cancer : A Multicentric Phase I/II Study of Fractionated TF2 Plus 90Y-IMP288 (RITCOLON)
Study Start Date : December 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: several cohorts

All patients will receive 3 injections of TF2 (the first: 14 mg/m², the second and the third:75 mg/m²). One day after each injection of TF2, the patient will receive a radiolabelled peptide (IMP-288) with Yttrium for therapeutic injectionThe First cohort will receive 555 MBq/m2 X 2 of 90-Y-IMP-288.:

All patient will receive 180 MBq of 111-In-IMP-288 for dosimetry analysis

Drug: Antibody TF2
injection of a recombinant antibody CEA specific. Three injections. Each injection are separate by one week

Drug: 90-Y-IMP-288
Injection of the peptide 90-Y-IMP-288, 24 Hours after injection of TF2. 2 injections by patients separated by one week (week 2 and week 3)

Drug: 111-In-IMP-288
Injection of the peptide 111-In-IMP-288, 24 Hours after the first injection of TF2 (week 1)




Primary Outcome Measures :
  1. To determine the maximum tolerated dose for 90Y-IMP288. [ Time Frame: Week 6 to week 12 ]
    toxicity analysis



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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. 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.
  2. Elevated CEA serum level or proved CEA expression in tumor tissue
  3. ≥ 18 years of age,
  4. Given signed, written informed consent
  5. 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.
  6. 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.
  7. Life expectancy ≥ 3 months, Karnofsky performance status of ≥ 70%
  8. Adequate hematology and renal function and hepatic function
  9. 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 :

  1. Known central nervous system metastatic disease
  2. > 25% bone marrow involvement
  3. CEA plasma levels >2,000 ng/mL
  4. 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.
  5. HIV positive, hepatitis B-antigen positive, or hepatitis C positive patients
  6. Known autoimmune disease,
  7. 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
  8. Infection requiring intravenous antibiotic use within 1 week before inclusion,
  9. 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.
  10. Patients who received a treatment containing a nitrosourea compound will not be enrolled for at least 6 weeks after the end of that treatment.
  11. Known hypersensitivity to murine antibodies or proteins
  12. Immunization against TF2 for patients who has already received injection of TF2
  13. Adult patient unable to give informed consent because of intellectual impairment.
  14. Adult patient protected by the French law

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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): NCT02300922


Locations
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France
CHU de Nantes
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02300922     History of Changes
Other Study ID Numbers: RC14_0003
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs