A Pharmacokinetic Study of Actinomycin-D and Vincristine in Children With Cancer
Recruitment status was Recruiting
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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 |
- 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 |
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 |
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| 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 | |
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 May 23, 2013