Myeloproliferative Neoplasms Clinical Trial

Ex Vivo Drug Sensitivity Testing and Mutation Profiling

Summary

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.

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Full Description

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.

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Eligibility Criteria

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.

Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

25

Study ID:

NCT03860376

Recruitment Status:

Active, not recruiting

Sponsor:

Florida International University

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There is 1 Location for this study

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Nicklaus Children's Hospital
Miami Florida, 33155, United States

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Study is for people with:

Myeloproliferative Neoplasms

Estimated Enrollment:

25

Study ID:

NCT03860376

Recruitment Status:

Active, not recruiting

Sponsor:


Florida International University

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