ADV1312: WEE1 Inhibitor MK-1775 and Irinotecan Hydrochloride in Treating Younger Patients With Relapsed or Refractory Solid Tumors

A Phase I/II Study of MK-1775 (AZD1775, IND# 121422) in Combination with Oral Irinotecan In Children, Adolescents, and Young Adults with Relapsed or Refractory Solid Tumors

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Relapsed or refractory solid tumors

Eligibility Overview:

  • Participant is >12 months and < 21 years of age at the time of study entry.
  • Participant has had histologic verification of malignancy at original diagnosis or relapse.
  • Participant has serum tumor markers including alpha-fetoprotein or beta-HCG.
  • Participant has a relapsed or refractory solid tumor.

Description

This is a Phase 1/2 study of a drug called AZD1775 (MK-1775) that will be given in combination with irinotecan. AZD1775 (MK-1775) is considered experimental because it has not been approved by the Food and Drug Administration (FDA). AZD1775 (MK-1775) has been used in only a small number of adults and this is the first time it is being used in children. New experimental drugs such as AZD1775 (MK-1775) are tested in an effort to find a drug that may be effective against tumors that have come back or that have not responded to standard therapy.

This is called a Phase 1 study because the goal of the first part of the study is to find the highest tolerable dose of AZD1775 (MK-1775) and irinotecan that can be given to participant with solid tumors. After that dose is determined, participants will enroll on the Phase 2 portion of the trial to look at the effect of AZD1775 (MK-1775) and irinotecan in participants with neuroblastoma.

Objectives

  • To find the highest tolerable dose of AZD1775 (MK-1775) in combination with irinotecan that can be given without causing severe side effects.
  • To learn what kind of side effects AZD1775 (MK-1775) in combination with irinotecan can cause.
  • To learn more about the pharmacology (how your body handles the drug) of AZD1775 (MK-1775).
  • To learn about how AZD1775 (MK-1775) functions in blood, bone marrow, or tumor tissue.
  • To determine whether AZD1775 (MK-1775) in combination with irinotecan is a beneficial treatment for these types of tumors.

Eligibility criteria, among others, include:

  • Participant is >12 months and < 21 years of age at the time of study entry.
  • Participant has had histologic verification of malignancy at original diagnosis or relapse.
  • Participant has serum tumor markers including alpha-fetoprotein or beta-HCG.
  • Participant has a relapsed or refractory solid tumor.
  • Participant’s current disease state is one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

Michael Bishop, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.