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

Investigating the Safety and Dosage of an Investigational Medication with Irinotecan for Solid Tumors in Children

Recruiting
1 years - 21 years
All
Phase N/A
1 Location

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.

Participants will be paid for their participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Supratentorial Promitive Neuroectodermal Tumor,Relapsed or Refractory Solid Tumors,Relapsed solid tumor,refractory solid tumor,relapsed,refractory,solid tumor,tumor,tumors,Medulloblastoma,Neuroblastoma,Supratentorial Promitive Neuroectodermal Tumor,Neuroectodermal Tumor,cancer,oncology,pediatric,kid,kids,child,children,youth,adolescent,teen,teens,teenager,teenagers,riley
  • Age: 1 years - 21 years
  • 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.

Updated on 19 Feb 2024. Study ID: 1404716151

This study investigates the use of an investigational medication in combination with irinotecan for treating children with solid tumors that have returned or not responded to standard treatments. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. The purpose of this study is to find the best dose of the investigational medication and to understand the side effects when used with irinotecan.

Participants in the study will receive the investigational medication and irinotecan on a specific schedule. The investigational medication is given on days 1 through 5 of a 21-day cycle. The study will also look at how the investigational medication moves through the body, known as pharmacokinetics, and any side effects that occur during the treatment.

  • Who can participate: Children with solid tumors that have either returned or not responded to standard therapy can participate. They must have had a confirmed diagnosis of cancer, except for certain brain tumors and conditions with specific tumor markers. Additionally, participants must have a disease state for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.
  • Study details: Participants will take the investigational medication and irinotecan on days 1 through 5 of a 21-day cycle. A placebo is not used in this study.

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