ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA
NCT ID: NCT01730612
Last Updated: 2018-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2012-12-31
2017-05-31
Brief Summary
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Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;
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Detailed Description
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Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours
Cohort II: based on the results of the cohort I :
1. Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6 nmol of IMP-288 / 30 hours
2. Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 / 18 hours
3. Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 / 3nmol IMP- 288 / 24 hours
Cohort III: based on results of cohort II:
\- Good signal of the tumor : dose reduction, 120 nmol TF2 / 3 nmol IMP-288 / 30 h
Cohort IV : based on results of cohort III Cohort V : Based on results of cohort IV
• A last Cohort (VI) : 19 patients with the optimal schedule of injection : 120 nmol TF2 / 3 nmol IMP-288 / 30 h or 120 nmol TF2 / 6 nmol IMP-288 / 30 h
• In the four weeks prior to the immuno-PET:
\- Clinical examination,
\- CEA and CA15-3,
\- thoraco abdominal pelvic scan, bone scan, FDG-PET,
\- immunohistochemistry ACE on the tumor if possible,
\- Anti-Antibodies if the patient has already received MAb,
\- pregnancy test within 2 days prior to immuno-PET,
\- (creatinine \> 2.5 normal) D0: Injection of TF2 D1 to D4: injection of 68 Ga-IMP-288 (depending of the cohort) D0 to D4 : pharmacokinetics, imaging
Evaluation at 1 month of Immuno-PET:
• Assessment of the clinical oncologist and
\- histological biopsy and / or surgery performed according to the results of imaging and assessment of the potential clinical impact
Evaluation at 3 and 6 months of immuno-PET:
based on the results of immuno-PET, evaluation and therapeutic decision of the oncologist,
\- Imaging (ultrasound, bone scintigraphy, CT or PET FDG),
\- markers
* Anti-Antibody Search
* For patient with a cancer treatment a new immuno-PET can be proposed
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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TF2 - 68 Ga-IMP-288:
ImmunoTEP
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years
* Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective contraception continuously for 3 months.
* Karnofsky ≥ 70 or ECOG 0-1
•• ACE of the tumor by immunohistochemistry or positive plasma CEA ≥ 10 ng / mL
* At least one measurable lesion on CT
* creatinine \< 2.5
* Informed consent signed
* Social insurance
Exclusion Criteria
* Serious illness or co-morbidity risk assessed
* History of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix
* Presence of anti-antibodies in patients who have previously received antibodies
* Known hypersensitivity to antibodies or proteins
* intellectual disability to sign the informed consent
* Not controlled diabetes
* Persons protected by law
18 Years
FEMALE
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Gilead Sciences
INDUSTRY
Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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francoise Bodere, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Nantes Hospital
Locations
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Hospital
Nantes, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
Countries
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Other Identifiers
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BRD/10/04-O
Identifier Type: -
Identifier Source: org_study_id
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