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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00491946
First received: June 22, 2007
Last updated: June 25, 2007
Last verified: June 2007
  Purpose

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


Condition Intervention Phase
Cancer
Drug: Actinomycin-D
Drug: Vincristine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 24
Study Start Date: June 2004
Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491946

Locations
United States, Pennsylvania
Abramson Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Donna Sylvester, RN, BSN, BA, CCRC    215-590-3284      
Principal Investigator: Jeffrey Skolnik, MD         
Sponsors and Collaborators
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00491946     History of Changes
Other Study ID Numbers: PPRU 10762
Study First Received: June 22, 2007
Last Updated: June 25, 2007
Health Authority: United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Cancer
Actinomycin
Vincristine

Additional relevant MeSH terms:
Dactinomycin
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents
Anti-Infective Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 22, 2014