Recruiting

Actinomycin-D & Vincristine

Sponsor:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Code:

NCT00491946

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Actinomycin-D

Vincristine

Study Details

Brief summary:

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

Conditions

Cancer

Study ID

NCT00491946

Start date

Jun, 2004

Status verified date

Jun, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 6 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

Exclusion Criteria:

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Actinomycin-D

Vincristine

Primary outcome measure

  • 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. [ Time Frame: undefined ]

Central Contacts and Locations

Locations

Abramson Research Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Donna Sylvester, RN, BSN, BA, CCRC

215-590-3284

Principal Investigator:

Jeffrey Skolnik, MD

More Information

Sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Last update posted

Jun 26, 2007

Last verified

Jun, 2007

Keywords

  • Cancer
  • Actinomycin
  • Vincristine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) on 2007-06-26.