Low Dose Versus Usual Dose Dexamethasone for Symptom Control in Children Undergoing Cranial or Craniospinal Radiation

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of low dose dexamethasone versus high dose dexamethasone in the treatment of radiation induced vomiting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: C17 Council
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria for Enrolment:

• Children between 2-18 years of age.

• Children who underwent resection of a brain tumour with ≤ 1.5 cm2 residual tumour after surgical resection.

• Children regardless of extent of leptomeningeal or spinal metastasis (M1-3) are eligible.

• Children who undergo focal or whole brain (± spinal) radiation as part of their brain tumour treatment.

• Children treated at one of the 16 tertiary care centers in Canada (CPBTC).

• Patients on any anticonvulsive treatment are eligible.

• Patients on concomitant chemotherapy while undergoing radiation are eligible.

• Patients must be ≥ 24 hours steroid-free prior to starting radiation.

• Parents/legal guardians have to have signed and dated an informed consent to allow study enrolment of their child. (As per institutional guidelines, patients over a certain age may have signed their own informed consent form.)

• Patients > 8 years of age should assent to study participation.

• Patients less than 10 years of age should have a Lansky Score of >/= 50.

• Patients 10 years of age or older should have a Karnofsky Score of >/= 50. If ECOG performance scale is used, patient should have a score of 0, 1 or 2.

Exclusion Criteria for Enrolment:

• Children with residual brain tumour lesion > 1.5 cm2 after surgical resection.

• Children on steroids (dexamethasone) that will not be stopped ≥ 24 hours prior to start of radiation therapy.

Inclusion Criteria for Randomization to a Dexamethasone treatment group:

• Patients must have been enrolled on the Dexamethasone study prior to the start of radiation therapy.

• Children who develop either symptoms of vomiting (defined as either retching or vomiting ≥ once per day) or headache (≥ 2 points increase in severity of the most intense headache/day) while undergoing irradiation.

• Patients who are currently undergoing focal or whole brain (± spinal) radiation.

Exclusion Criteria for Randomization to a Dexamethasone treatment group:

• Patients who were not enrolled on Dexamethasone study prior to start of radiation therapy.