Molecular-Guided Therapy for Childhood Cancer (NCT02162732) | Clinical Trial Compass
CompletedNot Applicable
Molecular-Guided Therapy for Childhood Cancer
United States186 participantsStarted 2014-07-08
Plain-language summary
The purpose of this study is to test the feasibility (ability to be done) of experimental technologies to determine a tumor's molecular makeup. This technology includes a genomic report based on DNA exomes and RNA sequencing that will be used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future.
Who can participate
Age range13 Months – 21 Years
SexALL
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Inclusion criteria
✓. Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies fitting into one of the following categories:
✓. Subjects must be age \>12 months at enrollment
✓. Subjects must be age ≤ 21 years at initial diagnosis
✓. Subjects must have measurable disease as demonstrated by residual abnormal tissue at a primary or metastatic site (measurable on CT or MRI) at the time of biopsy; tumor must be accessible for biopsy. In addition, subjects with bone or bone marrow only disease expected to be \>75% tumor are eligible to enroll.
✓. Current disease state must be one for which there is currently no known effective therapy
✓. Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.
✓. Lansky or Karnofsky Score must be ≥ 50
✓. Subjects without bone marrow metastases must have an ANC \> 750/μl to begin treatment.
Exclusion criteria
✕. Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to biopsy
✕. Subjects who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy).
What they're measuring
1
Days to Treatment Will be Used in Order to Determine Feasibility of Using Tumor Samples to Assess Genomic Sequencing Using Predictive Modeling to Make Real-time Treatment Decisions for Children With Relapsed/Refractory Cancers.
✕. Subjects receiving any investigational drug concurrently.
✕. Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor)
✕. Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study