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

Primary Purpose

Blastic Phase Chronic Myelogenous Leukemia, Childhood Central Nervous System Germ Cell Tumor, Childhood Choroid Plexus Tumor

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
romidepsin
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blastic Phase Chronic Myelogenous Leukemia

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

MTD, defined as that dose at which fewer than one-third of patients experience DLT, graded according to the NCI CTC version 2.0

Secondary Outcome Measures

Full Information

First Posted
February 5, 2003
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053963
Brief Title
FR901228 in Treating Children With Refractory or Recurrent Solid Tumors or Leukemia
Official Title
A PHASE I STUDY OF DEPSIPEPTIDE (NSC#630176, IND# 51810) IN PEDIATRIC PATIENTS WITH REFRACTORY SOLID TUMORS AND LEUKEMIAS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
romidepsin
Other Intervention Name(s)
FK228, FR901228, Istodax
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
MTD, defined as that dose at which fewer than one-third of patients experience DLT, graded according to the NCI CTC version 2.0
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Fouladi
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Oncology Group
City
Arcadia
State/Province
California
ZIP/Postal Code
91006-3776
Country
United States

12. IPD Sharing Statement

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

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