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Karenitecin in Pediatric Patients With Refractory or Recurrent Solid Tumors N10010)

NCT00586560 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-05-15

No results posted yet for this study

Summary

This is a Phase 1, open-label, single-center, dose-escalating study in pediatric patients with refractory or recurrent solid tumors. Patients will be registered into 1 of 2 strata, depending upon the presence bone marrow metastases or previous treatment with intensive myelosuppression therapy. Patients will receive Karenitecin along with cyclophosphamide daily for 5 consecutive days, every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, as long as there is continued evidence of clinical benefit and an absence of unacceptable toxicity.

Conditions

Interventions

DRUG

Kareniticin and cyclophosphamide

An accelerated titration dose escalation design will be used in this study. Dose escalation will function independently for each stratum. Patients in both strata will receive Karenitecin and cyclophosphamide administered as an IV infusion each day for 5 consecutive days. In addition, patients in Stratum 1 will receive prophylactic G-CSF starting 24 hours after completion of the fifth dose of Karenitecin and cyclophosphamide (and continuing daily until the ANC is over 1500/mm3 after nadir). The regimen will be repeated every 21 days (1 treatment cycle). Treatment may continue for up to 20 cycles, provided there is continued evidence of clinical benefit and absence of unacceptable toxicity.

Sponsors & Collaborators

  • Pediatric Brain Tumor Consortium

    collaborator NETWORK

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Susan Blaney, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00586560 on ClinicalTrials.gov