Clinical Trial: Pediatric MATCH: Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Advanced Refractory Solid Tumors or Lymphomas

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Brief Summary: This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors or lymphomas that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or lymphomas.

Detailed Summary:

PRIMARY OBJECTIVES:

I. 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, lymphomas, and histiocytic disorders.

II. To determine the proportion of pediatric patients whose advanced tumors have pathway alterations that can be targeted by select anti-cancer drugs.

III. To determine the objective response rates (ORR; complete response + partial response) in pediatric patients with advanced solid tumors, lymphomas, and histiocytic disorders harboring a priori specified genomic alterations treated with pathway-targeting agents.

SECONDARY OBJECTIVES:

I. To estimate the progression free survival in pediatric patients receiving targeted therapies for advanced solid tumors, lymphomas, and histiocytic disorders.

II. To obtain preliminary or additional information about the tolerability of targeted therapies in children with advanced cancers.

III. To provide preliminary estimates of the pharmacokinetics of targeted therapies in children with advanced cancers.

IV. To obtain preliminary information on the response rate to targeted therapy in patients whose tumors lack actionable alterations as defined for the molecular analysis for therapy choice (MATCH) study, for selected agents for which efficacy is observed in the primary matched cohort.

TERTIARY OBJECTIVES:

I. To increase knowledge of the genomic
Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Objective response rate (complete response/partial response) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 [ Time Frame: Up to 4 years ]

Response rates will be calculated as the percent of evaluable patients who are responders, and confidence intervals will be constructed using the Wilson score interval method.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of research biopsy related target toxicity as defined as any >= grade 3 toxicity or complication that is probably or definitely attributable to any biopsy-related anesthesia or imaging procedures that occurs within 14 days of research [ Time Frame: Up to 14 days ]
    Incidence of research biopsy related target toxicity will be assessed.
  • Incidence of toxicity assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 4 years ]
    Toxicity tables will be constructed to summarize the observed incidence by type of toxicity and grade. Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen.
  • Progression free survival [ Time Frame: From the initiation of protocol treatment to the occurrence of any of the following events: disease progression or disease recurrence or death from any cause, assessed up to 4 years ]
    Estimated using the Kaplan-Meier method along with confidence intervals.


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: May 15, 2017
Date Started: July 6, 2017
Date Completion: December 31, 2021
Last Updated: May 15, 2017
Last Verified: May 2017