NBTXR3 Crystalline Nanoparticles and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma of the Extremity
This study is currently recruiting participants.
Verified September 2011 by Nanobiotix
Sponsor:
Nanobiotix
Information provided by (Responsible Party):
Nanobiotix
ClinicalTrials.gov Identifier:
NCT01433068
First received: September 9, 2011
Last updated: December 5, 2011
Last verified: September 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | Allocation: Non-Randomized 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 |
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
- 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
Locally advanced soft tissue sarcoma,candidate to radiotherapy
- Primary tumor or,
- Relapsed tumor, localized out of already irradiated area
- 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
- Metastatic disease (CT-scan verification) with survival expectation < 6 months
- Concurrent treatment with any other anticancer therapy
- Moderate and severe liver dysfunction
- Hemolytic anemia
- Autoimmune disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433068
Contacts
| Contact: Micheline Enyegue, MSC | + 33 (0)1 40 26 06 27 | micheline.enyegue@nanobiotix.com |
| Contact: Elsa Borghi, MD | + 33 (0)1 40 26 26 87 | elsa.borghi@nanobiotix.com |
Locations
| France | |
| Institut Gustave Roussy | Recruiting |
| Villejuif, France, 94805 | |
| Contact: Sylvie Bonvalot, MD - PhD | |
| Contact: Eric Deutsch, MD-PhD | |
| Principal Investigator: Sylvie Bonvalot, MD-PhD | |
| Principal Investigator: Eric Deutsch, MD-PhD | |
Sponsors and Collaborators
Nanobiotix
Investigators
| Principal Investigator: | Sylvie Bonvalot, MD-PhD | Head of Surgery Division |
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: | December 5, 2011 |
| 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 |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on May 22, 2013