Irinotecan +Temozolomide for Neoplasm Metastasis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Universitaetsklinikum Freiburg, Freiburg, Germany
Neoplasm Metastasis+3 More
Irinotecan - Drug
Eligibility
< 65
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.

Eligible Conditions

  • Neoplasm Metastasis
  • Sarcoma, Ewing

Treatment Effectiveness

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Baseline to date of death due to any cause (estimated up to 45 months)

Month 45
Overall Survival (OS)
Month 11
Disease Control Rate (DCR)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR
Month 11
PFS
Progression Free Survival (PFS)
Day 21
Pharmacokinetics (PK): Minimum Plasma Concentration (Cmin) of Abemaciclib
Month 11
Duration of Response (DoR)
Day 21
Abemaciclib Product Acceptability

Trial Safety

Trial Design

2 Treatment Groups

Irinotecan +Temozolomide
1 of 2
Abemaciclib + Irinotecan +Temozolomide
1 of 2
Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: Irinotecan +Temozolomide · No Placebo Group · Phase 2

Irinotecan +TemozolomideExperimental Group · 2 Interventions: Irinotecan, Temozolomide · Intervention Types: Drug, Drug
Abemaciclib + Irinotecan +TemozolomideExperimental Group · 3 Interventions: Irinotecan, Abemaciclib, Temozolomide · Intervention Types: Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2010
Completed Phase 4
~4150
Abemaciclib
2019
Completed Phase 2
~1700
Temozolomide
2010
Completed Phase 3
~2700

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to date of death due to any cause (estimated up to 45 months)
Closest Location: Washington University · Saint Louis, MO
Photo of university of washington  1Photo of university of washington  2Photo of university of washington  3
2008First Recorded Clinical Trial
4 TrialsResearching Neoplasm Metastasis
512 CompletedClinical Trials

Eligibility Criteria

Age < 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The absolute neutrophil count is greater than or equal to 1000/µL.
You have platelets that are at least 75,000/mm³.
You have a hemoglobin level of 8 grams per decilitre (g/dl) or higher.
You have a total bilirubin level of 1.
AST and ALT ≤3 × ULN.
You have a minimum score of 50 on the Lansky or the Karnofsky scale.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.