NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Nanobiotix
Sponsor:
Information provided by (Responsible Party):
Nanobiotix
ClinicalTrials.gov Identifier:
NCT01433068
First received: September 9, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

RATIONALE: Radiation therapy given before surgery of soft tissue sarcoma decreases the size of the tumor mass and the presence of malignant cells in its peripheral region. NBTXR3 and radiation therapy may kill more cancer cells and increase the tumor shrinkage rendering surgery more feasible or easier and achieve better local control of the tumor.

PURPOSE: This Phase I trial aims at evaluating the feasibility of the NBTXR3 injection in the tumor, safety and the adequate dose of NBTXR3 when given with radiation therapy.


Condition Intervention Phase
Adult Soft Tissue Sarcoma
Device: NBTXR3
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single Arm, Feasibility And Safety Phase I Study With Nbtxr3 Intratumor Implantation (By Injection) And Activated By External Beam Radiation Therapy In Patients With Soft Tissue Sarcoma Of The Extremity And Trunk Wall

Resource links provided by NLM:


Further study details as provided by Nanobiotix:

Primary Outcome Measures:
  • Evaluation of the feasibility of the intratumor injection of NBTXR3 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    - To evaluate the feasibility of NBTXR3 given as intratumor implantation (by injection) and activated by external beam radiation in patients with soft tissue sarcoma of the extremity and trunk wall

  • Assessment of the safety profile and determination of early dose limiting toxicity [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
    - To assess the safety profile and determine the early dose limiting toxicity (DLT) of NBTXR3 intratumor implantation (by injection) and activated by external beam radiation


Secondary Outcome Measures:
  • Evaluation of the anti-tumor activity of NBTXR3 in terms of pathological Response (pR) [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    - To evaluate the anti-tumor activity of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy in terms of pathological Response (pR)

  • Evaluation of the Response Rate (RR) of NBTXR3 as per RECIST [ Time Frame: 20 months ] [ Designated as safety issue: No ]
    - To evaluate the Response Rate (RR) of NBTXR3 implanted within the tumor (by injection) at Day 1 and activated 24 hours later by external beam radiation therapy as per RECIST

  • Characterization of the body kinetic profile of NBTXR3 [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
    - To characterize the body kinetic profile of NBTXR3 implanted within the tumor (by injection) at Day 1 and Day 2 before its activation by radiation therapy


Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NBTXR3 Device: NBTXR3
One intratumor implantation by injection

Detailed Description:

Patients will receive a single intratumor injection of NBTXR3 on day 1 and will receive external beam radiotherapy starting on day 2 up to completion of 5 weeks, 5 days a week of treatment (50Gy, 2Gy/fraction). Then, all patients will undergo surgical resection of the tumor 5 weeks later and will be followed for wound healing and toxicity assessment. A visit of end of treatment will take place approximately 3-4 weeks after surgery. Patients will be followed for evaluation of their disease status and adverse events every 8 weeks until the end of study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 18 years and older
  • Soft tissue sarcoma of the extremity or trunk wall, or localized in the posterior region of the neck (i.e., coronal section passing through the posterior limit of the ear)
  • Locally advanced soft tissue sarcoma,candidate to radiotherapy

    • Primary tumor or,
    • Relapsed tumor, localized out of already irradiated area or,
    • Sarcomas secondary to previous irradiation exposure due to other primary cancer
  • WHO performance score 0 to 2
  • Adequate function of Bone marrow:
  • Adequate renal function
  • Adequate liver function
  • All female patients of childbearing potential must have a negative serum/urinary pregnancy test

Exclusion Criteria:

  • Written Informed Consent not obtained, signed and dated
  • Patients with the following histological type: Gastrointestinal Stromal Tumors (GIST), embryonal or alveolar rhabdomyosarcoma, Ewing's sarcoma, osteosarcoma or chondrosarcoma, Kaposi's sarcoma, primitive neuroectodermal tumor or dermatofibrosarcoma protuberans
  • Soft tissue sarcoma of the trunk wall localized in the abdominal region, i.e. the region defined cranially by the xiphoid process of the sternum and the costal margins, and caudally by the line joining the anterior superior iliac spines, both limited by the perpendicular lines crossing both nipples
  • Angiosarcoma of the trunk wall because of its diffuse frontier
  • Metastatic disease (CT-scan verification) with survival expectation < 6 months
  • Concurrent treatment with any other anticancer therapy
  • Absence of histologically or cytologically proven cancer at the first diagnosis
  • Previous neoadjuvant chemotherapy treatment given as an upfront of the current treatment line
  • Previous radiation therapy in relapse site of the soft tissue sarcoma (no radiation re-challenge is permitted)
  • Moderate and severe liver dysfunction
  • Hemolytic anemia
  • Autoimmune disease
  • Complete initial work up earlier than 4 weeks prior to patient registration
  • Patients unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • Patients participating in another clinical investigation at the time of signature of the informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433068

Contacts
Contact: Mikaela DIMITRIU, PhD mikaela.dimitriu@nanobiotix.com
Contact: Elsa BORGHI, MD elsa.borghi@nanobiotix.com

Locations
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Guy KANTOR         
Contact: Xavier BUY         
Principal Investigator: Guy KANTOR, MD-PhD         
Sub-Investigator: Paul SARGOS, MD         
Sub-Investigator: Xavier BUY, MD         
Sub-Investigator: Eberhard STOECKLE, MD         
Institut Gustave Roussy Recruiting
Villejuif, France, 94805
Contact: Sylvie BONVALOT, MD - PhD         
Contact: Eric DEUTSCH, MD-PhD         
Principal Investigator: Sylvie BONVALOT, MD-PhD         
Sub-Investigator: Eric DEUTSCH, MD-PhD         
Sponsors and Collaborators
Nanobiotix
Investigators
Principal Investigator: Sylvie BONVALOT, MD-PhD Head of Surgery Division
Principal Investigator: Guy KANTOR, MD-PhD Head of Radiotherapy Department
  More Information

No publications provided

Responsible Party: Nanobiotix
ClinicalTrials.gov Identifier: NCT01433068     History of Changes
Other Study ID Numbers: NBTXR3-101, ID RCB : 2011-A00342-39
Study First Received: September 9, 2011
Last Updated: January 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nanobiotix:
Adult Soft Tissue Sarcoma of the extremities and Trunk wall

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014