Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01946867
Recruitment Status : Unknown
Verified October 2016 by Nanobiotix.
Recruitment status was:  Recruiting
First Posted : September 20, 2013
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Nanobiotix

Tracking Information
First Submitted Date  ICMJE September 10, 2013
First Posted Date  ICMJE September 20, 2013
Last Update Posted Date March 28, 2017
Study Start Date  ICMJE August 2013
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
Determination of the Recommended Doses and the early Dose Limiting Toxicities (DLT) [ Time Frame: 18 months ]
To determine the Recommended Doses and the early Dose Limiting Toxicities (DLT) of NBTXR3 administered as two different schedules (intra-arterial or intratumor injection), activated by Intensity Modulated Radiation Therapy (IMRT)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01946867 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2013)
  • Evaluation of the safety and tolerability of NBTXR3 [ Time Frame: 24 months ]
    Safety and tolerability of NBTXR3, as an intra-arterial or intratumor injection schedule, activated by Intensity Modulated Radiation Therapy (IMRT) will be assessed in terms of incidence and severity of clinical and laboratory Adverse Events.
  • Evaluation of the Objective Response Rate (ORR) and the complete Response Rate as per Response Evaluation Criteria in Solid Tumors (RECIST) and the Tumor Volume estimation [ Time Frame: 24 months ]
    To evaluate the Objective Response Rate (ORR) and the complete Response Rate by Magnetic Resonance Imaging (MRI) using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) and the Tumor Volume estimation (Lenght×Width×Depth) of NBTXR3, as an intra-arterial or intratumor injection schedule, activated by Intensity Modulated Radiation Therapy (IMRT)
  • Evaluation of the Local Progression Free Survival (LPFS) [ Time Frame: 24 months ]
    To evaluate the local Progression Free Survival (lPFS) of NBTXR3, as an intra-arterial or intratumor injection schedule, activated by Intensity Modulated Radiation Therapy (IMRT)
  • Evaluation of the Progression Free Survival (PFS) of NBTXR3 [ Time Frame: 24 months ]
    To evaluate the Progression Free Survival (PFS) of NBTXR3, as an intra-arterial or intratumor injection schedule, activated by Intensity Modulated Radiation Therapy (IMRT)
  • Characterization of the body kinetics profile of NBTXR3 [ Time Frame: 18 months ]
    To characterize the body kinetics on Day 1 and 2, of NBTXR3 administered by intratumor or intra-arterial injection before its activation by Intensity Modulated Radiation Therapy (IMRT)
  • Evaluation of the feasibility of local administration either intratumor or intra-arterial route [ Time Frame: 18 months ]
    The feasibility of local administration, either intratumor or intra-arterial slow injection of NBTXR3, then activated by Intensity Modulated Radiation Therapy (IMRT) will be assessed by duration of injection, number of punctures, and in terms of the NBTXR3 nanoparticles intratumor dispersion.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Official Title  ICMJE PhI Study of NBTXR3 With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Brief Summary RATIONALE: Cancers of the oral cavity represent 30% of head and neck carcinomas in the western world. The oropharynx is the posterior continuation of the oral cavity and connects with the nasopharynx (above) and laryngopharynx (below). It is also a frequent site of primary head and neck cancers. These structures play a crucial role in swallowing, breath and speech. Locally advanced oropharyngeal cancers can obstruct the air flow or infiltrate muscles or nerves, which significantly disturb local functions. The incidence of Head and Neck Squamous Cell Cancer in patients older 65 years is high, 47% occurred in this population as recorded by the Surveillance, Epidemiology, and End Results registries in the United States. Regarding the therapeutic strategies, the association of radiotherapy with chemotherapy or biologics has demonstrated significant improvement of outcomes with the drawback of higher toxicity, or as demonstrated by 2 meta-analyses, without survival improvement in older patients. NBTXR3 and radiation therapy may increase the cancer cell killing and complete tumor shrinkage allowing a definitive treatment and preservation of local structures and functions in patients older 65 years, who cannot receive cisplatin.
Detailed Description Patients will receive a single administration of NBTXR3 on day 1, either as an intra-arterial or intratumor injection, followed by Intensity Modulated Radiation Therapy starting 24 hours later (day 2), and up to completion of 7 weeks, i.e. 70 Grays, 2Grays/fraction. Patients whose tumor has completely shrunk will be followed for the post-radiotherapy evaluation up to the End of Treatment visit. Those patients whose tumor has not shrunk more than 50% of the baseline size, will stop the radiotherapy and may have a salvage tumor surgery. Then, all patients will be followed every 8 weeks, for the safety evaluation and cancer disease status until the end of the study.
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE Device: NBTXR3
Study Arms
  • Experimental: NBTXR3 IntraTumoral injection (IT)
    Single intratumor injection
    Intervention: Device: NBTXR3
  • Experimental: NBTXR3 Intra-Arterial Injection (IA)
    Single intra-arterial injection
    Intervention: Device: NBTXR3
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 17, 2013)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged ≥ 70 years old
  • Patients aged ≥ 65 years old and < 70 years old with contra-indication to cisplatin
  • Patients that are intolerant to cisplatine or cetuximab or that cannot receive the combination of chemoradiation
  • Histologically or cytologically confirmed Squamous Cell Carcinoma (SCC) of the oral cavity or oropharynx
  • T3 or T4 primary tumor or Stage III or IVA according to American Joint Committee on Cancer guidelines (AJCC, 7th Edition, 2010)
  • No evidence of distant metastatic disease, as determined by a negative Positron Emission Tomography (PET Scan) or Computerized Tomography (CT Scan)
  • Clinically eligible for either intra-arterial or intratumor implantation by injection
  • KPS Karnofsky performance status) ≥ 70
  • Adequate function of Bone marrow:

    • White Blood Cell (WBC) > 3.0 x 109/l
    • Absolute neutrophil count (ANC) >= 1.0 x 109/l
    • Platelet count >= 100 x 109/l
    • Hemoglobin >= 9.0 g/dL
  • Adequate function of Kidney:

    • Creatinine <= 1.5 x ULN or creatinine clearance >= 50 mL/min/1.73m²
  • Adequate function of liver:

    • AST (Aspartate aminotransferase) <= 5 x ULN
    • ALT (Alanine aminotransferase) <= 5 x ULN
    • Bilirubin <= 1.5 x ULN

Exclusion Criteria:

  • Written Informed Consent not obtained, signed and dated
  • Prior radiotherapy to any area within the planned radiotherapy field
  • Tumor-related dyspnea
  • Tumor ulceration which implies vascular risk
  • Non measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  • History of stroke, Coronary Artery Bypass Graft (CABG), or significant blockage of carotid arteries or coronary arteries or current blockage of coronary or carotid arteries equal to or in excess of 50% blockage
  • Uncontrolled intercurrent illness including, but not limited to,ongoing or active severe infection, symptomatic congestive heart failure, acute coronary syndrome, etc.
  • Medical history of life-threatening ventricular arrhythmia
  • Prior or concurrent non-head and neck malignancies, excluding adequately treated basal or squamous cell cancer of the skin, and in situ cervical cancer, and any other cancer from which the subject has been cancer free for 5 years
  • Concurrent treatment with any other anticancer therapy, including chemotherapy, immunotherapy, targeted therapy, gene therapy, or patients planning to receive these treatments during the study
  • Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures or those with severe psychiatric illness/social situations that would limit compliance with study requirements
  • Patients participating in another clinical investigation at the time of signature of the informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01946867
Other Study ID Numbers  ICMJE NBTXR3-102
ID RCB: 2013-A00706-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Nanobiotix
Study Sponsor  ICMJE Nanobiotix
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe LE TOURNEAU, MD-PhD Medical Oncology Department
PRS Account Nanobiotix
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP