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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2007 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00491946
First Posted: June 26, 2007
Last Update Posted: June 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00491946     History of Changes
Other Study ID Numbers: PPRU 10762
First Submitted: June 22, 2007
First Posted: June 26, 2007
Last Update Posted: June 26, 2007
Last Verified: June 2007

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

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