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

NCT01433068 | Completed Phase 1 DMC

• 2 other identifiers: NBTXR3-101ID RCB : 2011-A00342-39
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Adult Soft Tissue Sarcoma

Keywords

Adult Soft Tissue Sarcoma of the extremities and Trunk wall

Outcome Measures

Primary Outcomes (2)

• 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

  6 months

• 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

  20 months

Secondary Outcomes (3)

• Evaluation of the anti-tumor activity of NBTXR3 in terms of pathological Response (pR)

  20 months

• Evaluation of the Response Rate (RR) of NBTXR3 as per RECIST

  20 months

• Characterization of the body kinetic profile of NBTXR3

  20 months

Study Arms (1)

NBTXR3

EXPERIMENTAL

Device: NBTXR3

Interventions

NBTXR3 DEVICE

One intratumor implantation by injection

NBTXR3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanobiotix: lead

Study Sites (2)

Institut Bergonie

Bordeaux, 33076, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Sylvie BONVALOT, MD-PhD

  Head of Surgery Division

  PRINCIPAL INVESTIGATOR

• Guy KANTOR, MD-PhD

  Head of Radiotherapy Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 13, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: February 1, 2015
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

FR (2)