FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia

Completed · Phase 1

Conditions studied: Blastic Phase Chronic Myelogenous Leukemia, Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor, Childhood Chronic Myelogenous Leukemia, Childhood Craniopharyngioma, Childhood Grade I Meningioma, Childhood Grade II Meningioma, Childhood Grade III Meningioma, Childhood High-grade Cerebral Astrocytoma, Childhood Infratentorial Ependymoma, Childhood Low-grade Cerebral Astrocytoma, Childhood Spinal Cord Neoplasm, Childhood Supratentorial Ependymoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Brain Stem Glioma, Recurrent Childhood Cerebellar Astrocytoma, Recurrent Childhood Cerebral Astrocytoma, Recurrent Childhood Ependymoma, Recurrent Childhood Medulloblastoma, Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor, Recurrent Childhood Visual Pathway and Hypothalamic Glioma, Refractory Chronic Lymphocytic Leukemia, Relapsing Chronic Myelogenous Leukemia, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

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

Key facts

Study ID

NCT00053963

Run by

National Cancer Institute (NCI)

People needed

30

Starts

2002-09-01

Last updated by the study team

2013-01-16

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 patients over 15 years of age)
• Calcium normal (with or without supplementation)
• Shortening fraction at least 27% by echocardiogram OR ejection fraction at least 50% by MUGA

Where it is running

• Children's Oncology Group — Arcadia, California, United States

Full record on ClinicalTrials.gov

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