Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Epen… (NCT05057702) | Clinical Trial Compass
RecruitingNot Applicable
Individualized Treatment Plan in Children and Young Adults With Relapsed Medulloblastoma and Ependymoma
United States74 participantsStarted 2022-02-22
Plain-language summary
The current study will use a new treatment approach based on the molecular characteristics of each participant's tumor. The study will test the feasibility in the pilot phase of performing real-time drug screening on tissue taken during surgery in patients with relapsed medulloblastoma or ependymoma and of having a specialized tumor board assign a treatment plan based on the results of this screening and genomic sequencing. The aim of this trial is to allow every child and young adult with relapsed medulloblastoma and ependymoma to receive the most effective and least toxic therapies currently available and will pave the way for improved understanding and treatment of these tumors in the future. Moreover, if successful, it could serve as a paradigm for personalized medicine programs for other types of cancer.
Who can participate
Age range12 Months – 39 Years
SexALL
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Inclusion criteria
✓. Participants must have recurrent medulloblastoma or recurrent ependymoma previously histologically confirmed. Participants must be experiencing their first or second relapse to be eligible.
✓. Participants must have surgically accessible disease.
✓. Prior Therapy:
✓. The participant must have received at least one prior therapy at the time of initial diagnosis.
✓. Relapsed medulloblastoma or relapsed ependymoma are eligible.
✓. Participants must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and would be eligible for surgical resection per institutional guidelines
✓. Participant must be a candidate for surgical resection or biopsy with anticipated ability to obtain the minimum tissue requirements for study.
✓. Radiation - Participants must have:
Exclusion criteria
✕
What they're measuring
1
Number of participants for whom treatment recommendations are fully completed within 21 business days of tissue collection based on drug screening (Pilot Phase)
Timeframe: Up to 21 days
2
Percentage of participants with treatment recommendations within 21 business days (Pilot Phase)
Timeframe: Up to 21 days
3
Number of participants without adequate tissue
Timeframe: Up to 21 days
4
Median Time from tissue collection to issued treatment plan from the specialized tumor board (Pilot Phase)
Timeframe: Up to 21 days
5
Median Progression-free survival (PFS) (Efficacy Phase)
. Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
✕. Participants who are receiving any other investigational agents.
✕. Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such participants should also be discussed with study chairs.
✕. Participants who are currently taking any anti-cancer direct therapy. Steroids are not considered anti-cancer therapy.
✕. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
✕. Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required prior to start of therapy.
✕. Participants must not receive any tumor-directed therapy after enrollment, except for surgical resection/ biopsy.