COG,APEC1621MAS, Ph2 ,open label, Rel/Ref AdvSolidTumors, NHL, MATCH master&screen

Summary

Primary Aims -To utilize clinical and biological data to screen for eligibility to phase 2 pathway-targeting specific subprotocols of pathway-targeting agents in pediatric patients with advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders. -To determine the proportion of pediatric patients whose advanced tumors have pathway alterations that can be targeted by select anti-cancer drugs. -To determine the objective response rates (ORR; complete response + partial response) in pediatric patients with advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders harboring a priori specified genomic alterations treated with pathway-targeting agents. Secondary Aims -To estimate the progression free survival in pediatric patients receiving targeted therapies for advanced solid tumors, non-Hodgkin lymphomas, and histiocytic disorders. -To obtain preliminary or additional information about the tolerability of targeted therapies in children with advanced cancers. -To provide preliminary estimates of the pharmacokinetics of targeted therapies in children with advanced cancers. -To obtain preliminary information on the response rate to targeted therapy in patients whose tumors lack actionable alterations as defined for the MATCH study, for selected agents for which efficacy is observed in the primary matched cohort.


Inclusion Criteria

  • ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must be >= 12 months and =< 21 years of age at the time of study enrollment
  • ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphomas, histiocytoses (e.g. langerhans cell histiocytosis [LCH], juvenile xanthogranuloma [JXG], histiocytic sarcoma), and central nervous system (CNS) tumors are eligible; 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); in cases where patient enrolls prior to histologic confirmation of recurrent disease, patient is ineligible and should be withdrawn from study if histology fails to confirm recurrence; please note: Patients with Hodgkin lymphoma and plexiform neurofibroma are not eligible
  • ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Tumor Testing Requirement: Tumor sample availability requirement for stage 1 of Pediatric MATCH (patients enrolled from start of study in July 2017 through 12/31/21); Patients must have an formalin-fixed paraffin-embedded (FFPE) tumor sample available for MATCH study testing from a biopsy or surgery that was performed at any point after initial tumor recurrence/progression, or be planned to have a procedure to obtain such a sample that is considered to be of potential benefit by the treating clinicians; a tumor sample from a clinically performed diagnostic (pre-treatment) biopsy will be acceptable for enrollment onto Pediatric MATCH only for children with high-grade gliomas of the brainstem (diffuse intrinsic pontine gliomas) or thalamus
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Study Location(s)

Cedars-Sinai Cancer at SOCC

More about this Clinical Trial

Full Title

APEC1621MASTER-APEC1621SC: NCI-COG Pediatric MATCH Master and Screening Protocol

Details
Disease Type/Condition

Bones and Joints, Brain and Nervous System, Ill-Defined Sites, Kidney, Non-Hodgkin's Lymphoma, Soft Tissue

Principal Investigator

Majlessipour, Fataneh

Co-Investigators

Nicole Baca

Age Group

Both

Phase

II

IRB Number

Pro00057413

ClinicalTrials.gov ID

NCT03155620

Key Eligibility
ClinicalTrials.gov

Contact
Email
cancer.trial.info@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Bones and Joints, Brain and Nervous System, Ill-Defined Sites, Kidney, Non-Hodgkin's Lymphoma, Soft Tissue

Principal Investigator

Majlessipour, Fataneh

Age Group

Both

Phase

II

IRB Number

APEC1621MASTER-APEC1621SC

ClinicalTrials.gov ID

NCT03155620

Key Eligibility
ClinicalTrials.gov

Contact
Email
cancer.trial.info@cshs.org
Want to join the study or
learn more?