COZMOS : Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain and Solid Tumors

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

1-18Age 1-18

Brain and Spinal<br/>CancersCancer LocationBrain and Spinal
Cancers

Systemic therapy,Treatment | Brain and spinal cordBrain,Central Nervous System,Ependymomas

Trial Overview Read MoreRead more

This phase I trial is testing a cancer drug that works by switching on genes to stop cancer growth, to see if it is a suitable treatment for children whose brain cancer has not responded to, or has gotten worse on, prior treatment.
 

This trial is treating patients with brain cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

Phase I/Ib Trial of Combined 5'Azacitidine and Carboplatin for Recurrent/Refractory Pediatric Brain and Solid Tumors

Other Non-Commercial Sponsor

The Hospital for Sick Children

Summary

This is a dose escalation and expansion trial. In the dose escalation phase of the trial, eligible patients will receive 75mg/m2/day 5'azacytidine on Days 1-7. This will be followed by escalating doses of carboplatin on Day 14, using a rolling 6 design. In this phase of the trial, carboplatin will be dosed initially at AUC 4. For dose level -1 the dose of 5'azacytidine will be reduced to to 50mg/m2/day. The dose expansion phase will be split into two arms according to whether eligible patients have a posterior fossa- or supratentorial- ependymoma. In both arms, patients will receive 5'azacytidine (on days 1-7) and carboplatin (on day 14) at the maximum tolerated dose achieved in the dose escalation phase.

Recruiting Hospitals Read MoreRead more

Royal Childrens Hospital
Parkville
Trial Coordinator
CCC.ClinicalTrials@rch.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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