NCT00491946

Brief Summary

To obtain a preliminary characterization of the plasma PK and metabolites of actinomycin-D in children with cancer.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4 cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2007

Completed
Last Updated

June 26, 2007

Status Verified

June 1, 2007

First QC Date

June 22, 2007

Last Update Submit

June 25, 2007

Conditions

Cancer

Keywords

CancerActinomycinVincristine

Outcome Measures

Primary Outcomes (1)

  • Characterization of Plasma Pharmacokinetics to examine the optimal dosing, metabolites and inter-patient variability of actinomycin-D in children with cancer during any sample of chemotherapy.

Interventions

Actinomycin-DDRUG
VincristineDRUG

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • months - 18 years
  • Due to receive actinomycin-D as a component of cancer treatment
  • Central venous catheter (e.g. Port-a Cath, Broviac)
  • Informed consent of parent or legal guardian and patient assent when appropriate

You may not qualify if:

  • Serious illness other than the primary diagnosis of cancer
  • Weight \< 5 kilograms
  • Previous participation in CHP-810

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Research Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

DactinomycinVincristine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingIndolizidinesIndolizines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

June 22, 2007

First Posted

June 26, 2007

Study Start

June 1, 2004

Last Updated

June 26, 2007

Record last verified: 2007-06

Locations

US(1)