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NCT00491946 Clinical Trial

A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

Cancer Clinical Trial

Official title:
A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00491946
Other study ID # PPRU 10762
Secondary ID
Status Recruiting
Phase Phase 4
First received June 22, 2007
Last updated June 25, 2007
Start date June 2004

Study information
Verified date June 2007
Source Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

Description:

There is a fundamental lack of knowledge regarding optimal dosing of anti-cancer agents for young children with cancer, with resultant increased risk of morbidity, mortality and inferior outcome. Of the anti-cancer agents used frequently in infants and young children, the drug with the least amount of knowledge is actinomycin-D. Actinomycin-D, has been used for the treatment of several childhood cancers since the 1960s. Despite its longstanding and widespread use in pediatric oncology, there is virtually no pharmacokinetic information from which safe and appropriate age-based pediatric dosing can be derived. Actinomycin-D is an integral component of rhabdomyosarcoma and Wilms tumor therapy, and pediatric oncologists will continue to administer the durg despite the gap in knowledge.

Recruitment information / eligibility
Status Recruiting
Enrollment 24
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Actinomycin-D

• Vincristine

Locations
Country Name City State
United States Abramson Research Center Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
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