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International Pleuropulmonary Blastoma (PPB) Treatment and Biology Registry

NCT01464606 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-08-21

No results posted yet for this study

Summary

Pleuropulmonary Blastoma (PPB) is very rare and there is no established "standard" or "best" therapy. For many years, children with PPB around the world have been treated according to decisions made case-by-case in many different hospitals by many different physicians. No treatment has been tested in a large group of PPB patients.

The goal is to treat many children with one treatment program and to learn the results of the treatment.

Conditions

  • Pleuropulmonary Blastoma

Interventions

DRUG

Vincristine

≥ 3 years: 1.5 mg/m2 IV x 1 (maximum dose 2 mg)

DRUG

Dactinomycin

≥ 3 years: 0.045 mg/kg (maximum dose 2.5 mg) IV X 1

DRUG

Cyclophosphamide

≥ 3 year: 1.2 gm/m2/dose IV as 1 hr infusion with IV fluids

DRUG

Ifosfamide

≥ 3 years: 3 g/m2/dose IV over 3 hours on Days 1, 2, (6 g/m2/cycle)

DRUG

Doxorubicin

≥ 3 years: 30 mg/m2/dose IV over 30 min, Days 1, 2 (60 mg/m2/cycle)

Sponsors & Collaborators

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Principal Investigators

  • Kris Ann P Schultz, MD · Children's Hospitals and Clinics of Minnesota

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-22
Primary Completion
2025-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01464606 on ClinicalTrials.gov