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

Primary Purpose

Adult Soft Tissue Sarcoma

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
NBTXR3
Sponsored by
Nanobiotix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Soft Tissue Sarcoma focused on measuring Adult Soft Tissue Sarcoma of the extremities and Trunk wall

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Bergonie
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NBTXR3

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the feasibility of the intratumor injection of NBTXR3
- 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
- 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)
- 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
- 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
- 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

Full Information

First Posted
September 9, 2011
Last Updated
October 4, 2020
Sponsor
Nanobiotix
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1. Study Identification

Unique Protocol Identification Number
NCT01433068
Brief Title
NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanobiotix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Soft Tissue Sarcoma
Keywords
Adult Soft Tissue Sarcoma of the extremities and Trunk wall

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NBTXR3
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
NBTXR3
Intervention Description
One intratumor implantation by injection
Primary Outcome Measure Information:
Title
Evaluation of the feasibility of the intratumor injection of NBTXR3
Description
- 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
Time Frame
6 months
Title
Assessment of the safety profile and determination of early dose limiting toxicity
Description
- 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
Time Frame
20 months
Secondary Outcome Measure Information:
Title
Evaluation of the anti-tumor activity of NBTXR3 in terms of pathological Response (pR)
Description
- 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)
Time Frame
20 months
Title
Evaluation of the Response Rate (RR) of NBTXR3 as per RECIST
Description
- 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
Time Frame
20 months
Title
Characterization of the body kinetic profile of NBTXR3
Description
- 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
Time Frame
20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie BONVALOT, MD-PhD
Organizational Affiliation
Head of Surgery Division
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guy KANTOR, MD-PhD
Organizational Affiliation
Head of Radiotherapy Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

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

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