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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Cancer

Keywords

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Cancer Actinomycin Vincristine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Actinomycin-D

Intervention Type DRUG

Vincristine

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Abramson Research Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Donna Sylvester, RN, BSN, BA, CCRC

Role: primary

Other Identifiers

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PPRU 10762

Identifier Type: -

Identifier Source: org_study_id