Neuroblastoma Maintenance Therapy Trial

Conditions

• Neuroblastoma

Eligibility Criteria

Sex

ALL

Age

1 Year - 30 Years

Healthy Volunteers

Not accepted

Interventions

• Difluoromethylornithine (DFMO) — DRUG
  Subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study.

Study Details

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.

Key Dates

Start date

Feb 29, 2016

Status verified

Jan 2026

Primary completion

Feb 29, 2028

Completion

Feb 28, 2033

Study Design

Enrollment

441 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Arms

• Experimental: Difluoromethylornithine (DFMO)
  Subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study.

Primary Outcome Measure

Number of participants with event free survival (EFS) during study. [ Time Frame: 2 years ]

Central Contacts

• BCC Enroll
  7175310003
  [email protected]

Locations (42)

Find similar trials in Birmingham, AL

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