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A Pharmacokinetic Participation Questionnaire Study


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Leukemia, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A Pharmacokinetic Participation Questionnaire Study


OBJECTIVES:

- To use a simple 2-page survey to gather preliminary information on why patients or
parents/guardians (if patient is a minor) do or do not agree to participate in the
optional pharmacokinetic portion of a phase I treatment study while consenting to
participate in the phase I treatment study.

OUTLINE: This is a multicenter study.

Patients or parents/guardians (if patient is a minor) complete a short questionnaire on the
reasons for agreeing/declining to participation in the optional pharmacokinetic sampling
component of the phase I clinical trial.

Patient demographics and other relevant information are collected.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Patients or their parents/guardians (if patient is a minor) consented to participate
in a phase I treatment clinical trial with an optional pharmacokinetic (PK)
component, within the past 4 weeks

- Must not have withdrawn consent for the phase I treatment study

- Patients or their parents/guardians are eligible regardless of whether they
initially agreed to participate in the PK sampling

- Must not withdraw consent for PK sampling prior to completing the
study questionnaire if initially agreed to optional PK sampling

- Patients or their parents/guardians are eligible regardless of whether they
actually completed PK sampling (provided reasons for not completing the
sampling was not withdrawal of the initial consent to the phase I treatment
study)

PATIENT CHARACTERISTICS:

- Not cognitively or physically impaired

- May participate no more than once in the study questionnaire survey

PRIOR CONCURRENT THERAPY:

- No limit on participation in the number of prior phase I trials or other studies

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Correlation between study questionnaire answers and patient demographics

Safety Issue:

No

Principal Investigator

Elizabeth Fox, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000616064

NCT ID:

NCT00890435

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Leukemia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • unspecified childhood solid tumor, protocol specific
  • recurrent childhood brain stem glioma
  • recurrent childhood cerebellar astrocytoma
  • recurrent childhood cerebral astrocytoma
  • recurrent childhood medulloblastoma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood ependymoma
  • recurrent childhood pineoblastoma
  • recurrent childhood subependymal giant cell astrocytoma
  • recurrent childhood visual pathway and hypothalamic glioma
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • childhood choroid plexus tumor
  • childhood craniopharyngioma
  • childhood ependymoblastoma
  • childhood medulloepithelioma
  • childhood meningioma
  • childhood mixed glioma
  • childhood oligodendroglioma
  • adult astrocytic tumors
  • adult brain stem glioma
  • adult choroid plexus tumor
  • adult craniopharyngioma
  • adult ependymoblastoma
  • adult medulloblastoma
  • adult supratentorial primitive neuroectodermal tumor (PNET)
  • adult ependymal tumors
  • adult meningeal tumor
  • adult mixed glioma
  • adult oligodendroglial tumors
  • adult pineal parenchymal tumor
  • recurrent adult brain tumor
  • relapsing chronic myelogenous leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • secondary acute myeloid leukemia
  • acute undifferentiated leukemia
  • mast cell leukemia
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • T-cell large granular lymphocyte leukemia
  • refractory chronic lymphocytic leukemia
  • childhood chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • juvenile myelomonocytic leukemia
  • refractory hairy cell leukemia
  • prolymphocytic leukemia
  • Leukemia
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms

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