NCT00053963

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

3.4 years

First QC Date

February 5, 2003

Last Update Submit

January 15, 2013

Conditions

Blastic Phase Chronic Myelogenous LeukemiaChildhood Central Nervous System Germ Cell TumorChildhood Choroid Plexus TumorChildhood Chronic Myelogenous LeukemiaChildhood CraniopharyngiomaChildhood Grade I MeningiomaChildhood Grade II MeningiomaChildhood Grade III MeningiomaChildhood High-grade Cerebral AstrocytomaChildhood Infratentorial EpendymomaChildhood Low-grade Cerebral AstrocytomaChildhood Spinal Cord NeoplasmChildhood Supratentorial EpendymomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood EpendymomaRecurrent Childhood MedulloblastomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway and Hypothalamic GliomaRefractory Chronic Lymphocytic LeukemiaRelapsing Chronic Myelogenous LeukemiaUnspecified Childhood Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (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

    Up to 28 days

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: romidepsin

Interventions

romidepsinDRUG

Given IV

Also known as: FK228, FR901228, Istodax
Arm I

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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)
  • +40 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Blast CrisisChoroid Plexus NeoplasmsAstrocytomaSpinal Cord NeoplasmsPrecursor Cell Lymphoblastic Leukemia-LymphomaFamilial ependymomaMedulloblastomaOptic Nerve GliomaLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebral Ventricle NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueSpinal Cord DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve DiseasesEye DiseasesLeukemia, B-Cell

Study Officials

  • Maryam Fouladi

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2003

First Posted

February 6, 2003

Study Start

September 1, 2002

Primary Completion

February 1, 2006

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)