FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia (NCT00053963) | Clinical Trial Compass
CompletedPhase 1
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
United States30 participantsStarted 2002-09
Plain-language summary
This phase I trial is studying the side effects and best dose of FR901228 in treating children with refractory or recurrent solid tumors or leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed malignancy
* Extracranial solid tumors or brain tumors\*
* Diagnosis of leukemia allowed after maximum tolerated dose is determined, including any of the following:
* Acute lymphoblastic leukemia
* Acute myelogenous leukemia
* Chronic myelogenous leukemia in blast crisis
* Disease must be refractory to conventional therapy or no effective conventional therapy exists
* CNS tumors resulting in neurological deficits must be stable for 2 weeks before study entry
* Performance status - Karnofsky 60-100% (over 10 years old)
* Performance status - Lansky 60-100% (10 years old and under)
* At least 8 weeks
* Absolute neutrophil count at least 1,000/mm\^3 (for solid tumor patients without bone marrow involvement)
* Platelet count at least 100,000/mm\^3 (for solid tumor patients without bone marrow involvement; platelet transfusion independent) OR 20,000/mm\^3 (for leukemia patients; platelet transfusion allowed)
* Hemoglobin at least 8.0 g/dL (RBC transfusions allowed)
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 5 times ULN
* Albumin at least 2 g/dL
* Glomerular filtration rate at least 70 mL/min
* Creatinine based on age as follows:
* No greater than 0.8 mg/dL (for patients 5 years of age and under)
* No greater than 1.0 mg/dL (for patients 6 to 10 years of age)
* No greater than 1.2 mg/dL (for patients 11 to 15 years of age)
* No greater than 1.5 mg/dL (for patientsā¦
What they're measuring
1
MTD, defined as that dose at which fewer than one-third of patients experience DLT, graded according to the NCI CTC version 2.0