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Anti-metabolites

Pembrolizumab + Decitabine + Radiation for Cancer

Phase < 1
Waitlist Available
Led By Brian Turpin, DO
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age: greater than or equal to 12 months and less than or equal to 40 years
Patients must have had histologic verification of malignancy at original diagnosis or relapse. Eligible diagnoses include relapsed or refractory solid tumors (excluding primary CNS tumors) and lymphoma in second or greater relapse or with refractory disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 cycles (56 days)
Awards & highlights

Study Summary

This trial is assessing the safety and preliminary effectiveness of a combination of pembrolizumab, decitabine, and radiation therapy in children and young adults with relapsed, refractory, or progressive non-CNS solid tumors and lymphomas.

Who is the study for?
This trial is for pediatric and young adult patients (12 months to 40 years old) with relapsed, refractory or progressive non-CNS solid tumors and lymphomas. They must have a history of cancer verified by tests, adequate organ function, no severe cardiac disease, not pregnant or breastfeeding, and not on other investigational drugs. Patients who've had certain treatments like stem cell infusions need to wait specific periods before joining.Check my eligibility
What is being tested?
The study is testing the safety and potential effectiveness of combining pembrolizumab (an immune therapy drug), decitabine (a chemotherapy drug), and targeted radiation therapy in children and young adults with tough-to-treat cancers. The goal is to see if this combo can help control the cancer better than current methods.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system that may affect organs, fatigue from treatment, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will depend on how each patient's body reacts to the combination of therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 1 year and 40 years old.
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My cancer was confirmed by a lab test and has come back or didn’t respond to treatment.
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I have a cancer lesion that can be targeted with radiation.
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I can do most activities but need help with some.
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I have recovered from side effects of my previous cancer treatments.
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My current condition has no cure or treatments that would extend my life with good quality.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 cycles (56 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 cycles (56 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of administering Pembrolizumab in combination with Decitabine and hypofractionated index radiation
Secondary outcome measures
Define anti-tumor efficacy of treatment combination of pembrolizumab, decitabine, and hypofractionated index radiation (per irRECIST criteria)
Identification of treatment related toxicities and tolerability

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab, Decitabine, RadiationExperimental Treatment3 Interventions
Patients will receive pembrolizumab and decitabine every 28 days, and a single 3 day course of fixed-dose hypofractionated radiotherapy to one or more index lesions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Decitabine
2004
Completed Phase 3
~1680

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor
815 Previous Clinical Trials
6,531,576 Total Patients Enrolled
5 Trials studying Lymphoma
339 Patients Enrolled for Lymphoma
Brian Turpin, DOPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03445858 — Phase < 1
Lymphoma Research Study Groups: Pembrolizumab, Decitabine, Radiation
Lymphoma Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT03445858 — Phase < 1
Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03445858 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment offer enrollment for individuals aged sixty or older?

"Due to the eligibility standards of this experiment, only individuals between 12 months and 40 years can be enrolled."

Answered by AI

What previous investigations have been conducted utilizing Pembrolizumab?

"Currently, the number of active clinical trials investigating Pembrolizumab is 1058, with 137 studies in Phase 3. Not only can Houston residents seek out treatments for this medication, but there are 37236 other locations across USA offering it as well."

Answered by AI

How many participants are participating in this experiment?

"Unfortunately, this trial is not taking any more participants at the moment. It was initially posted on February 12th 2018 and last modified May 24th 2022. However, there are other studies available: 4009 trials accommodating patients with lymphoma and 1058 involving Pembrolizumab that require enrolment."

Answered by AI

For whom is this research opportunity available?

"This trial is looking to enroll 21 individuals with lymphoma between the ages of 12 months and 40 years. The eligibility requirements comprise relapsed or refractory solid tumours, a minimum time period since the last dose of hematopoietic growth factor, evaluable/measurable disease amenable to radiation along with no known curative therapies for their current medical condition. Furthermore, patients who have previously undergone therapy involving inhibitors of PD-1, PD-L1, CTLA4 or other immune checkpoint inhibitors are permitted – provided they did not experience an adverse event that necessitated treatment using steroids or immunomodulatory drugs"

Answered by AI

What medical conditions can be addressed with the use of Pembrolizumab?

"Pembrolizumab is commonly used to treat unresectable melanoma, as well as microsatellite instability high conditions, those with a heightened risk of relapse, and other illnesses."

Answered by AI

Are applications to this clinical trial still being accepted?

"This medical trial, which was initially announced on February 12th 2018 and modified recently on May 24th 2022, is not at this moment recruiting patients. Nevertheless, there are over 5000 other trials actively looking for volunteers right now."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults
2018. "Pembrolizumab in Combination With Decitabine and Hypofractionated Index Lesion Radiation in Pediatrics and Young Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03445858.
~0 spots leftby Jun 2024
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