AGuIX Gadolinium-based Nanoparticles in Combination With Chemoradiation and Brachytherapy

  • STATUS
    Recruiting
  • days left to enroll
    6
  • participants needed
    18
  • sponsor
    Gustave Roussy, Cancer Campus, Grand Paris
Updated on 22 January 2021
cancer
coronary artery disease
absolute neutrophil count
adenocarcinoma
external beam radiotherapy
aguix-np

Summary

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).

Details
Condition Gynecologic Cancer
Treatment External Beam Radiotherapy (EBRT), Chemotherapy (Cisplatin), Polysiloxane Gd-Chelates based nanoparticles (AGuIX), Uterovaginal brachytherapy
Clinical Study IdentifierNCT03308604
SponsorGustave Roussy, Cancer Campus, Grand Paris
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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, 18-FDG PET and Coelioscopic para-aortic lymph node staging
ECOG performance status 0-1
Age between 18 - 70 years
Neutrophils> 2000 / mm3
Hemoglobin> 9 g / l after transfusion if necessary
Platelets> 100,000 / mm3
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
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