Description:

ADVL0212: Eligibility Worksheet FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia NCT00053963 Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC07E8-6588-30D1-E034-0003BA12F5E7

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1EC07E8-6588-30D1-E034-0003BA12F5E7

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  1. 8/26/12
  2. 1/9/15
  3. 3/20/15
Uploaded on:

March 20, 2015

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Creative Commons BY-NC 3.0 Legacy
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Refractory tumors in children (NCT00053963)

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  1. StudyEvent: ADVL0212: Eligibility Worksheet
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Header
Eligibility criteria
Is the planned start of treatment within seven days of fulfilling all eligibility criteria? (To be eligible, planned start of treatment must be within seven days of fulfilling all eligibility criteria.)
Is patient less than 22 years of age at the time of study entry? (To be eligible, patient must be less than 22 years of age at the time of study entry.)
Does patient have histologic verification of the malignancy at original diagnosis? (To be eligible, the patient must have histologic verification of the malignancy at original diagnosis.)
Is patient's disease considered refractory to conventional therapy, or is there no existing effective conventional therapy? (To be eligible, patient's disease must be considered refractory to conventional therapy, or there is no existing effective conventional therapy.)
If patient has a CNS tumor, were neurologic deficits relatively stable for a minimum of two weeks prior to study entry? (To be eligible, if patient has a CNS tumor, neurologic deficits must have been relatively stable for a minimum of two weeks prior to study entry.)
Karnofsky Performance Score (To be eligible, patients greater than 10 years of age must have a Karnofsky performance status greater than or equal to 60.)
Lansky Play Score (To be eligible, patients less than or equal to 10 years of age must have a Lansky play status greater than or equal to 60.)
Does patient have a life expectancy of greater than or equal to 8 weeks? (To be eligible, the patient must have a life expectancy of greater than or equal to 8 weeks.)
Has patient fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study? (Myleosuppressive chemotherapy: Must not have received within 3 weeks of entry onto this study 4 weeks if prior nitrosourea.)
Did patient receive growth factors within 1 week of entry onto this study? (To be eligible, patient must not have received growth factors within 1 week of entry onto this study.)
If patient has a CNS tumor and is receiving dexamethasone, is patient on a stable dose for at least two weeks prior to study entry? (To be eligible, if patient has a CNS tumor and is receiving dexamethasone, patient must be on a stable dose for at least two weeks prior to study entry.)
Is patient receiving enzyme-inducing anticonvulsant drugs? (To be eligible, patient must not be receiving enzyme-inducing anticonvulsant drugs.)
Does patient have adequate bone marrow function? (To be eligible, patient must have adequate bone marrow function as defined below:)
Does patient have adequate renal function? (To be eligible, patient must have adequate renal function as defined below:)
Does patient have adequate liver function? (To be eligible, patient must have adequate liver function as defined below:)
Does patient have adequate cardiac function? (To be eligible, patient must have adequate cardiac function as defined below:)
Does patient have adequate pulmonary function? (To be eligible, patient must have adequate pulmonary function as defined below:)
Does patient have adequate central nervous system function? (To be eligible, patient must have adequate central nervous system function as defined below:)
If female and post-menarchal, was a pregnancy test obtained? (To be eligible, if female and post-menarchal, a pregnancy test must be obtained.)
If patient is of reproductive potential, has he or she agreed to use an effective contraceptive method? (To be eligible, if patient is of reproductive potential, he or she must agree to use an effective contraceptive method.)
Does patient have an uncontrolled infection? (To be eligible, patient must not have an uncontrolled infection.)
Has patient previously received depsipeptide? (To be eligible, patient must not have previously received depsipeptide.)
Does patient have the following: Symptoms of congestive heart failure, Uncontrolled cardiac rhythm disturbance, or QTC that is greater than or equal to 480 msec (To be eligible, patient must not have any of the above characteristics.)
Has the patient and/or the parents or legal guardians signed a written informed consent? (To be eligible, the patient and/or the parents or legal guardians must have signed a written informed consent.)
Have all institutional, FDA, and NCI requirements for human studies been met? (To be eligible, all institutional, FDA, and NCI requirements for human studies must have been met.)