- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03308604
AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy (NANOCOL)
Phase I Study of AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy in Locally Advanced Cervical Cancer
This is a phase 1 clinical trial evaluating the safety, tolerability of escalating doses of AGuIX-NP in combination with radiation and cisplatin in patients with locally advanced cervical cancer. Dose escalation will be conducted using the modified toxicity probability interval (mTPI) method.
Three dose levels of intravenous AGuIX nanoparticles will be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2).
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Cyrus CHARGARI, MD
- Phone Number: 33 65 +33 (0) 1 42 11 42 11
- Email: cyrus.chargari@gustaveroussy.fr
Study Contact Backup
- Name: Matthieu TEXIER
- Phone Number: +33 (0) 1 42 11 62 52
- Email: matthieu.texier@gustaveroussy.fr
Study Locations
-
-
Rhône
-
Pierre-Bénite, Rhône, France, 69310
- Not yet recruiting
- Centre Hospitalier Lyon Sud
-
Contact:
- Ionela CARAIVAN, MD
- Phone Number: +33 (0) 4 78 86 42 60
- Email: ionela.caraivan@chu-lyon.fr
-
Principal Investigator:
- Ionela CARAIVAN, MD
-
-
Val De Marne
-
Villejuif, Val De Marne, France, 94800
- Recruiting
- Gustave Roussy
-
Contact:
- Cyrus CHARGARI, MD
- Phone Number: 33 65 +33 (0) 1 42 11 42 11
- Email: cyrus.chargari@gustaveroussy.fr
-
Contact:
- Matthieu TEXIER
- Phone Number: +33 (0) 1 42 11 62 52
- Email: matthieu.texier@gustaveroussy.fr
-
Principal Investigator:
- Cyrus CHARGARI, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with histologically confirmed cancer of the uterine cervix: squamous cell carcinoma or adenocarcinoma stage IB2-IVA according to the International Federation of Gynecology and Obstetrics classification, regardless of the pelvic lymph node stage. No evidence of metastatic disease. Primary staging should include: clinical examination, Pelvic MRI and 18-FDG PET. A coelioscopic para-aortic lymph node staging should be done in patients without para-aortic lymph node uptake to guide radiotherapy fields in the situation of pelvic lymph node metastases. If there is no pelvic lymph node metastases, para-aortic lymph node dissection is optional.
- ECOG performance status 0-1.
- Age between 18 - 70 years.
- Neutrophils > 2000/mm^3.
- Hemoglobin > 9 g/L after transfusion if necessary.
- Platelets > 100,000/mm^3.
- Creatinine < 1.5 upper limit of normal or calculated creatinine clearance (Cockcroft-Gault Formula) ≥ 60 mL/min.
- Liver function (GOT, GPT, alkaline phosphatase and bilirubin) < 1.5 upper limit of normal.
- Cardiovascular: no clinically relevant cardiovascular disease, no congestive heart failure, no symptomatic coronary artery disease, no poorly controlled cardiac arrhythmia, no myocardial infarction within the past year.
- Gastrointestinal: no active inflammatory bowel disease, no lack of physical integrity of the upper gastrointestinal tract, no malabsorption syndrome.
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to initiation of treatment.
- Proteinuria < 2 g/L (200mg/dL) and creatinine clearance ≥ 60 mL/min.
- Signed informed consent after informing the patient.
- Patient affiliated to a social security regimen or beneficiary of the same.
Exclusion Criteria:
- Other histological types of cervical cancer than those listed in the inclusion criteria or stage IVB.
- History of cancer other than basal cell carcinoma within five past years.
- Prior treatment with radiotherapy, chemotherapy, targeted therapy or immune therapy for cervical cancer or for any cancer within five past years.
- Prior pelvic radiotherapy or prior surgical treatment for cervical cancer (excluding diagnostic conisation).
- Pregnancy or breastfeeding.
- Obesity (Body Mass Index > 30).
- History of prior or current psychiatric illness.
- Nephropathy, regardless of the grade.
- Peripheral neuropathy ≥ grade 2.
- Patients with pre-existing hearing impairments.
- Active infection or other serious underlying pathology that could prevent the patient from receiving the treatment (especially liver or heart conditions).
- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- Positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Inclusion in another clinical trial protocol with an experimental molecule (during this study or within 5 years prior to enrollment).
- Unable to undergo the follow-up required by study for geographical, social or psychological reasons.
- Contra-indication for Magnetic Resonance Imaging enhanced with gadolinium and/or any contra-indication to the use of cisplatin.
- History of allergic reaction to cisplatin or other platinum containing compounds.
- Concurrent administration of yellow fever vaccine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with locally advanced cervical cancer
|
Three intravenous injections of AGuIX will be delivered. The first injection of AGuIX will be delivered intravenously the 1st day and the 11th day of EBRT. The first injection will be preceded with an MRI (unenhanced T1 and T2 sequences) then followed with another MRI performed 4 hours later, to monitor tumor uptake. Irradiation will be performed after the second MRI. The second injection will be followed by an MRI 4 hours later. The third injection will be delivered intravenously the day of the brachytherapy procedure. Intravenous hydration will be performed during all brachytherapy courses to ensure AGuIX clearance. Up to three dose levels may be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2). The starting dose level will be 30mg/kg.
to the pelvis, with intensity modulated technique: 45 Gy in 5 weeks, with integrated boost to 55 - 57.5 Gy in case of macroscopic lymph node metastases
15 Gy (maximal interval between EBRT and brachytherapy: 14 days).
Concomitant weekly intravenous cisplatin 40 mg/m2 will be delivered (total 5 cycles).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum Tolerated Dose (MTD)
Time Frame: Day 84 after inclusion
|
Day 84 after inclusion
|
Recommended Phase 2 Dose (RP2D)
Time Frame: Day 84 after inclusion
|
Day 84 after inclusion
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Cyrus CHARGARI, MD, Gustave Roussy, Cancer Campus, Grand Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-005127-83
- 2016/2508 (Other Identifier: CSET number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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