PHO-COG-CROOP-ADVL1312; A Phase 1/2 Study of AZD1775 (MK-1775) in Combination With Oral Irinotecan in Children Adolescents and Young Adults With Relapsed or Refractory Solid Tumors
James Croop, MD, PhD
Primary Investigator
Brief description of study
This phase I/II trial studies the side effects and best dose of WEE1 inhibitor MK-1775 and irinotecan hydrochloride in treating younger patients with solid tumors that have come back or that have not responded to standard therapy. WEE1 inhibitor MK-1775 and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description of study
The purpose of this study us to estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of MK-1775 (WEE1 inhibitor MK-1775) administered on days 1 through 5 every 21 days, in combination with oral irinotecan (irinotecan hydrochloride), to children with recurrent or refractory solid tumors; to define and describe the toxicities of MK-1775 in combination with oral irinotecan administered on this schedule; and to characterize the pharmacokinetics of MK-1775 in children with refractory cancer.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medulloblastoma,Neuroblastoma,Supratentorial Promitive Neuroectodermal Tumor
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Age: Between 1 Years - 21 Years
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Gender: All
Inclusion Criteria
In order to be eligible to take part in this trial, patients must meet the following criteria:
- Patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)
- Patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
For a full list of participation criteria, please visit ClinicalTrials.gov.
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