Ex Vivo Drug Sensitivity Testing and Mutation Profiling
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Lymphoma, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | Any - 21 |
| Updated: | 3/3/2019 |
| Start Date: | February 21, 2019 |
| End Date: | December 15, 2022 |
| Contact: | Diana Azzam, PhD |
| Email: | dazzam@fiu.edu |
| Phone: | 305-348-9043 |
Personalized Ex Vivo Drug Screening and Genomics Profiling to Guide Individualized Treatments for Children With Relapsed or Refractory Solid Tumors and Leukemias
This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells
from patients will be screened using state-of-the-art viability assay designed for ex vivo
high-throughput drug sensitivity testing (DST). In addition, genetic information will be
obtained from cancer and normal (germline) tissue and correlated with drug response. This
study will provide the platform for informing treating physician about individualized
treatment options. The main outcome of this study will be the proportions of the patients
whose treatment was guided by the personalized medicine approach.
from patients will be screened using state-of-the-art viability assay designed for ex vivo
high-throughput drug sensitivity testing (DST). In addition, genetic information will be
obtained from cancer and normal (germline) tissue and correlated with drug response. This
study will provide the platform for informing treating physician about individualized
treatment options. The main outcome of this study will be the proportions of the patients
whose treatment was guided by the personalized medicine approach.
PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of
providing pediatric cancer patients with access to personalized treatment options and
clinical management recommendations based on ex vivo drug sensitivity testing (DST) and
genomic profiling.
SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes
(response and disease-free survival) in patients with pediatric cancers treated with
DST-guided therapy as compared to non-DST guided (conventional) therapy.
EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies
and ex vivo drug response.
providing pediatric cancer patients with access to personalized treatment options and
clinical management recommendations based on ex vivo drug sensitivity testing (DST) and
genomic profiling.
SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual outcomes
(response and disease-free survival) in patients with pediatric cancers treated with
DST-guided therapy as compared to non-DST guided (conventional) therapy.
EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies
and ex vivo drug response.
Inclusion Criteria:
- Patients aged 21 years or younger at the time of enrollment on this study of any
gender, race or ethnicity.
- Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer
- Subjects who are scheduled for or have recently had biopsy or tumor excised
(solid tumors) or bone marrow aspirate (blood cancers)
- Subjects willing to have a blood draw or buccal swab done for the purposes of
genetic testing
- Subjects or their parents or legal guardians willing to sign informed consent
- Subjects aged 7 to 17 willing to sign assent
Exclusion Criteria:
- Subjects who do not have malignant tissue available and accessible
- The amount of excised malignant tissue is not sufficient for the ex vivo drug testing
and/or genetic profiling.
- Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with
safe standard therapy.
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