ADVL08N1: A Pharmacokinetic Participation Questionnaire Study
18 Years
N/A
Both
Relapsed Solid Tumors, Relapsed Leukemia, Relapsed Brain Tumors
Trial Information
ADVL08N1: A Pharmacokinetic Participation Questionnaire Study
Background:
Pharmacokinetic studies provide critical information about the disposition of anticancer
drugs in children. However, participation of children in the pharmacokinetic portion of
phase I studies is optional when there is not prospect of direct benefit to the child.
The rate of participation in optional PK studies on COG Phase I Consortium Studies has been
60-70%.
There are no recent data on why families do or do not agree to participate in optional PK
studies. Understanding families' reasons may reveal barriers to participation that could be
overcome, leading to increased participation rates in optional PK sampling.
Objectives:
To use a simple 2 page survey to gather preliminary information on why parents/children
agree to participate in Phase I Studies do or do not agree to participate in the voluntary
pharmacokinetic (PK) portion of those studies.
Eligibility:
Subjects (greater than or equal to 18 years old) or parents/guardians of subjects who are
minors who consented to Phase I studies with optional PK sampling with the previous 4 weeks.
Consent for the primary Phase I treatment protocol must be active (not withdrawn).
No limit on the number of prior Phase I studies in which the subject or subject's child
participated.
Subjects may only participate in this study once.
Design:
The individual who provided consent to the treatment study that included optional PK
sampling will complete a short questionnaire.
Subjects (n=50) from a convenience sample will complete and return the questionnaire.
Reasons for participating or agreeing to participate will be tabulated. Correlations between
answers and subject demographics, time required by PK, need for additional IV will be
sought.
Subjects will meet off study criteria when the questionnaire is returned, lost to follow up,
or consent for data submission to this or the primary treatment protocol is withdrawn.
The total accrual is 50 subjects. Accrual ceiling at the POB, NCI is 25 subjects.
Inclusion Criteria
- INCLUSION CRITERIA:
- Subjects who consented within the 4 weeks prior to enrollment on this questionnaire
study to a Phase 1 study that included optional PK sampling. (If the subject was a
minor and a parent or legally authorized representative provided consent, subject
for this questionnaire study refers to the parent). The PK questionnaire should be
completed within 4 weeks of when the subject consented to the study that included
optional PK sampling. (Note: The Phase 1 study need not have been a COG study).
- Subjects are eligible regardless of whether they initially agreed to participate in
the PK portion and regardless of whether they actually completed the PK sampling (as
long as reason for not completing the sampling was not withdrawal of consent).
- Subjects must not have withdrawn consent to the study that included optional PK
sampling.
- Subjects must not have initially agreed to optional PK sampling but then withdrawn
consent for sampling prior to completing the questionnaire.
- Subjects are eligible regardless of how many phase 1 or other studies they have
enrolled in the past.
- Each subject may participate only once in the survey.
Type of Study:
Observational
Study Design:
Time Perspective: Prospective
Authority:
United States: Federal Government
Study ID:
080223
NCT ID:
NCT00923468
Start Date:
September 2008
Completion Date:
Related Keywords:
- Relapsed Solid Tumors
- Relapsed Leukemia
- Relapsed Brain Tumors
- Pharmacokinetics
- Phase I Trials
- Children
- Relaspsed Solid Tumors
- Relapsed Leukemia
- Relapsed Brain Tumors
- Brain Neoplasms
- Leukemia
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
