NCT00109031 - Palifermin for the Reduction of Oral Mucositis in Single-dose Evaluation (PROMISE) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

February 28, 2006

Study Completion Date

December 31, 2010

Conditions

CancerLymphomaLeukemia

Interventions

DRUG

palifermin

Administered as one daily intravenous bolus.

RADIATION

Total Body Irradiation

To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days.

DRUG

Cyclophosphamide

Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2

DRUG

Etoposide

Etoposide may be administered (optional) as a single intravenous infusion over 4 hours on the day after the last fTBI fraction.

DRUG

Placebo

Administered as one daily intravenous bolus.