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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Adult Soft Tissue Sarcoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the feasibility of the intratumor injection of NBTXR3

Outcome 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

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Sylvie Bonvalot, MD-PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Head of Surgery Division

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

NBTXR3-101

NCT ID:

NCT01433068

Start Date:

October 2011

Completion Date:

May 2014

Related Keywords:

  • Adult Soft Tissue Sarcoma
  • Adult Soft Tissue Sarcoma of the extremities
  • Sarcoma

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