Patient-Derived Xenograft (PDX) Modeling in Adult Patients With Metastatic or Recurrent Sarcoma

Champions Oncology

Status: Terminated

Conditions: Sarcoma

Treatments: Other: PDX drug sensitivity testing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02720796

CO-001

Details and patient eligibility

About

Patients with recurrent or metastatic sarcoma will be consented to develop a patient derived xenograft (PDX or TumorGraft) model of their tumor to perform drug sensitivity testing. The purpose of the study is to evaluate the accuracy of the patient derived xenograft (PDX) model in predicting patient clinical response to the same drug treatment.

Enrollment: 17 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 15 years of age or older
• Patients with metastatic sarcoma who have had no more than one prior systemic treatment for metastatic disease
• Patients with recurrent sarcoma at relapse
• Patients with confirmed histological diagnosis of sarcoma or suspected diagnosis of sarcoma. Some specific subtypes of sarcoma are NOT eligible (Gastrointestinal Stromal Tumor (GIST), carcinosarcoma, sarcomatoid mesothelioma, and metastatic phyllodes tumor)
• If initial suspected diagnosis of sarcoma, must have sarcoma diagnosis confirmed prior to proceeding with PDX drug sensitivity testing
• Must have measureable disease for computed tomography (CT) scan or magnetic resonance imaging (MRI) evaluation following biopsy or surgery to obtain tissue for PDX development.
• No plan for concurrent chemoradiation, for target lesions that will be used for drug treatment correlation with PDX
• Fresh tumor tissue available for PDX development
• Eastern Cooperative Oncology Group performance status of 0-1
• Life expectancy exceeds 6 months
• Plan to receive systemic therapy
• Informed consent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

17 participants in 1 patient group

PDX drug sensitivity testing

Other group

Description:

Patient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician.

Treatment:

Other: PDX drug sensitivity testing