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| Sponsor: | Children's Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00053963 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Leukemia Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: romidepsin |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Study of Depsipeptide (NSC#630176, IND#51810) in Pediatric Patients With Refractory Solid Tumors and Leukemias |
| Study Start Date: | December 2002 |
OBJECTIVES:
Primary
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.
PROJECTED ACCRUAL: A total of 3-30 patients (3-24 with solid tumors and up to 6 with leukemia) will be accrued for this study within 2 years.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignancy
Diagnosis of leukemia allowed after maximum tolerated dose is determined, including any of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Creatinine based on age as follows:
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Palo Alto, California, United States | |
| United States, District of Columbia | |
| Children's National Medical Center | |
| Washington, District of Columbia, United States | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States | |
| United States, Maryland | |
| NCI - Pediatric Oncology Branch | |
| Bethesda, Maryland, United States | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States | |
| United States, Minnesota | |
| Fairview University Medical Center - University Campus | |
| Minneapolis, Minnesota, United States | |
| Mayo Clinic Cancer Center | |
| Rochester, Minnesota, United States | |
| United States, Mississippi | |
| University of Mississippi Medical Center | |
| Jackson, Mississippi, United States | |
| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University | |
| New York, New York, United States | |
| SUNY Upstate Medical University Hospital | |
| Syracuse, New York, United States | |
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphia | |
| Philadelphia, Pennsylvania, United States | |
| Children's Hospital of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | |
| Memphis, Tennessee, United States | |
| United States, Texas | |
| Baylor University Medical Center - Houston | |
| Houston, Texas, United States | |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | |
| Dallas, Texas, United States | |
| United States, Washington | |
| Children's Hospital and Regional Medical Center - Seattle | |
| Seattle, Washington, United States | |
| Study Chair: | Maryam Fouladi, MD | Children's Hospital Medical Center, Cincinnati |
More Information
| Study ID Numbers: | CDR0000269671, COG-ADVL0212, NCI-03-C-0307 |
| Study First Received: | February 5, 2003 |
| Last Updated: | August 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00053963 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified childhood solid tumor, protocol specific recurrent childhood acute lymphoblastic leukemia blastic phase chronic myelogenous leukemia recurrent childhood acute myeloid leukemia refractory chronic lymphocytic leukemia relapsing chronic myelogenous leukemia childhood chronic myelogenous leukemia childhood central nervous system germ cell tumor childhood choroid plexus tumor childhood craniopharyngioma childhood infratentorial ependymoma childhood grade I meningioma childhood grade II meningioma |
childhood grade III meningioma childhood spinal cord neoplasm childhood supratentorial ependymoma recurrent childhood brain stem glioma recurrent childhood cerebellar astrocytoma recurrent childhood ependymoma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood medulloblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood visual pathway and hypothalamic glioma |
|
Leukemia Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Romidepsin Central Nervous System Neoplasms Antibiotics, Antineoplastic Pharmacologic Actions Nervous System Neoplasms |