Spots Global Cancer Trial Database for Dose-Escalation Study of Pixantrone Monotherapy in Pediatric Patients With Relapsed or Refractory Cancer

Study Description

Brief Summary: This is a phase 1, open-label, dose escalation study to evaluate the safety, pharmacokinetics, and antitumor activity of pixantrone in pediatric patients with relapsed or refractory solid tumors (excluding those with CNS tumors) or lymphoma.

Detailed Description: Approximately thirty-five eligible patients will receive up to six 28-day cycles of pixantrone monotherapy, with two additional cycles in patients who continue to benefit from treatment. Each patient will receive pixantrone administered intravenously on days 1, 8, and 15 of each 28-day cycle. There will be three age cohorts, defined as age cohort 1 (12 to less than 18 years, plus young adults (ages 18-21 years)), age cohort 2 (5 to less than 12 years), and age cohort 3 (6 months to less than 5 years). During dose escalation, three patients will first be accrued to the starting dose level. If no DLTs are identified, that dose level will be declared to not exceed the MTD and three patients will be accrued to the next higher dose level. Each subsequent dose-escalation level will be accrued per the DLT/MTD determination schema above. Planned sequential dose-escalation phase will receive 40 mg/m2, 50 mg/m2, 60 mg/m2 or 70 mg/m2 of pixantrone base (on days 1, 8 and 15), as tolerated, based on DLT evaluation.Dose escalations will follow a standard 3+3 patient cohort escalation plan. No patients from Age Cohort 3 will be enrolled until 6 patients from age cohorts 1 and 2 (combined) are evaluable for toxicity. After the MTD has been determined, an expansion phase will be accrued in order to gain better estimates of the safety, tolerability, and anti-tumor activity of pixantrone monotherapy in pediatric patients when treated at the MTD. Patients will be offered 3 years of post-study extension phase follow-up with periodic assessments of cardiac function parameters.

Keywords

Eligibility

Minimum Age: 6 Months

Eligible Ages: CHILD, ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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