BMNIRN: Talazoparib Plus Irinotecan With or Without Temozolomide in Children with Refractory or Recurrent Solid Malignancies

A Phase I Study of Talazoparib (BMN 673) Plus Irinotecan With or Without Temozolomide in Children with Refractory or Recurrent Solid Malignancies

Categories:

Solid Tumor

Phase I/II

Diseases Treated:

Relapsed or refractory solid tumors

Eligibility Overview:

  • Participant has refractory or recurrent solid tumor for which there is no standard therapy.
  • Participant has had histologic verification of malignancy at original diagnosis or at the time of relapse.
  • Participant is twelve (12) months to twenty-five (25) years of age at the time of enrollment on study.
  • Participant life expectancy is at least eight (8) weeks. 

Description

This study will enroll participants who have a solid tumor that has comeback (recurrent) or has not responded to previous therapy (refractory) and who meet certain eligibility criteria. People with solid tumors that comeback or do not respond to therapy may get other chemotherapy, surgery, or radiation therapy for certain cancers. One or more of these may be considered standard treatment. Right now there is no standard treatment for your cancer. The doctors in this study will be testing the experimental drug combination of Talazoparib (formerly called BMN673) and Irinotecan to see whether it will be effective against the type of cancer like the one (s) participants asked to be in this study may have. Also in this study the doctors want to find the safest dose of Irinotecan given with Talazoparib to children and young adults.

Goals

  • To determine whether the combination of Talazoparib and Irinotecan is a beneficial treatment for solid tumor cancers.
  • To learn what kind of side effects Talazoparib can cause.
  • To learn what kind of side effects Talazoparib in combination with Irinotecan can cause.
  • To learn more about the biology of Talazoparib in children diagnosed with solid tumors.

Inclusion: (among others)

  • Participant has refractory or recurrent solid tumor for which there is no standard therapy.
  • Participant has had histologic verification of malignancy at original diagnosis or at the time of relapse.
  • Participant is twelve (12) months to twenty-five (25) years of age at the time of enrollment on study.
  • Participant life expectancy is at least eight (8) weeks.
  • Participant has not received myelosuppressive chemotherapy within three (3) weeks of enrollment onto this study (six weeks if prior nitrosurea).
  • At least seven (7) days have elapsed since the completion of therapy with a growth rate factor; at least four-teen (14) days after receiving pegfilgrastim.
  • At least two (2) weeks have elapsed since any irradiation.

Exclusion: (among others)

  • Participant is pregnant or breast-feeding.
  • Participant is receiving other investigational drugs.
  • Participant has received prior treatment with Talazoparib.
  • Participant has prior solid organ transplant
  • Participant has prior total body irradiation.

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

Sara Federico, 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

Referring or consulting clinicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: 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.