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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages N/A - 21 Years
Gender All
More Inclusion & Exclusion Criteria

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 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.
  • - No symptomatic congestive heart failure.
  • - No uncontrolled cardiac arrhythmia.
  • - QTc less than 450 msec.
  • - No evidence of dyspnea at rest.
  • - No exercise intolerance.
  • - Pulse oximetry greater than 94% - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception during and for 1 month after completion of study treatment.
  • - Magnesium and potassium normal (with or without supplementation) - No uncontrolled seizure disorder.
  • - No uncontrolled infection.
  • - No graft-vs-host disease.
  • - No seizure disorder unless well controlled and not on enzyme-inducing anticonvulsants.
  • - At least 1 week since prior growth factors.
  • - At least 3 weeks since prior biologic therapy or immunotherapy and recovered.
  • - At least 6 months since prior allogeneic stem cell transplantation.
  • - No concurrent routine prophylactic growth factors.
  • - At least 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered.
  • - No prior FR901228 (depsipeptide) - No other concurrent anticancer chemotherapy.
  • - Concurrent dexamethasone for CNS tumors allowed if on stable dose or decreasing dose for at least 1 week before study entry.
  • - Recovered from prior radiotherapy.
  • - At least 2 weeks since prior local palliative radiotherapy (small port) - At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of pelvis.
  • - At least 6 weeks since other prior substantial bone marrow radiation.
  • - More than a 5 half-life washout period since prior and no concurrent medications associated with prolongation of QTc interval.
  • - No concurrent enzyme-inducing anticonvulsants.
  • - No concurrent hydrochlorothiazide.
- No other concurrent investigational drugs

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00053963
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 National Cancer Institute (NCI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Maryam Fouladi
Principal Investigator Affiliation Children's Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being 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
Additional Details

PRIMARY OBJECTIVES:

  • I. Determine the maximum tolerated dose (MTD) of FR901228 (depsipeptide) in pediatric patients with refractory or recurrent solid tumors.
  • II. Determine the dose-limiting toxic effects of this drug in these patients.
  • III. Determine the pharmacokinetics of this drug in these patients.
  • IV. Assess tolerability of this drug at the solid tumor MTD in patients with refractory or recurrent leukemia.
  • V. Determine, preliminarily, the antitumor activity of this drug in these patients.
OUTLINE: This is a dose-escalation, multicenter study. Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients with solid tumors receive escalating doses of FR901228 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Cohorts of 3 patients (6 patients total) with leukemia receive FR901228 as above at the MTD. Patients are followed for survival.

Arms & Interventions

Arms

Experimental: Arm I

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Interventions

Drug: - romidepsin

Given IV

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Children's Oncology Group, Arcadia, California

Status

Address

Children's Oncology Group

Arcadia, California, 91006-3776

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