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Anti-metabolites

5 Azacytidine for Ependymoma (COZMOS Trial)

Phase 1
Waitlist Available
Led By Vijay Ramaswamy, MD PhD FRCPC
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

COZMOS Trial Summary

This trial is testing azacitidine combined with carboplatin to see if it's safe and effective for treating brain and solid tumors in kids.

Eligible Conditions
  • Solid Tumors
  • Ependymoma
  • Childhood Central Nervous System Tumor

COZMOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Establish maximum tolerated dose of carboplatin in combination with 5'azacytidine
Secondary outcome measures
Assessment of disease response as a preliminary indication of efficacy of this combination against recurrent, refractory pediatric brain and solid tumors
Assessment of intratumoral DNA demethylation as a preliminary indication of biological efficacy of this combination.
Characterization of the pharmacodynamics of 5'-azacitidine in combination with carboplatin

COZMOS Trial Design

3Treatment groups
Experimental Treatment
Group I: Recurrent Brain and Solid Tumour Expansion ArmExperimental Treatment1 Intervention
5'azacytidine will be administered on days 1-7 and carboplatin will be administered on day 14 at the maximum tolerated dose achieved in the Phase I dose escalation up to 12 patients with recurrent/refractory brain and solid tumour.
Group II: Posterior Fossa Ependymoma Expansion ArmExperimental Treatment1 Intervention
5'azacytidine will be administered on days 1-7 and carboplatin will be administered on day 14 at the maximum tolerated dose achieved in the Phase I dose escalation to 20 patients with recurrent/refractory posterior fossa ependymoma.
Group III: Phase I Dose-escalationExperimental Treatment1 Intervention
5'azacytidine will be administered on Days 1-7 at a dose of 75mg/m2/day, followed by escalating doses of Carboplatin on Day 14 in a rolling 6 design. Carboplatin will be dosed initially at AUC 4. Dose level -1 will reduce 5'azacytidine to 50mg/m2/day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
689 Previous Clinical Trials
6,945,390 Total Patients Enrolled
Vijay Ramaswamy, MD PhD FRCPCPrincipal Investigator - The Hospital for Sick Children
The Hospital for Sick Children
Daniel Morgenstern, MD PhDPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
COZMOS:Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain/Solid Tumors
Vijay Ramaswamy 2017. "COZMOS:Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain/Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03206021.
~4 spots leftby Apr 2025
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