- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003370
Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. Determine the maximum tolerated dose and dose limiting toxicity of 6-hydroxymethylacylfulvene (MGI-114) in pediatric patients with recurrent or refractory solid tumors.
II. Determine the incidence and severity of other toxic effects of MGI-114. III. Determine a safe and tolerable dose of MGI-114 to be used in phase II studies.
IV. Determine the pharmacokinetics of MGI-114 in these patients. V. Determine preliminary evidence of antitumor activity of MGI-114 against recurrent or refractory pediatric solid tumors.
OUTLINE: This is a dose escalation study. If the dose limiting toxicity is myelosuppression in stratum 1, then stratum 1 is closed and stratum 2 opens.
Stratum 2 consists of the following: patients receiving no more than 2 prior chemotherapy regimens; patients who have not received prior central axis radiation or bone marrow transplantation; and patients with no known bone marrow involvement. Patients receive intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days. The course is repeated every 28 days unless disease progression or unacceptable toxic effects are observed. Patients with stable or responding disease may receive up to 1 year of therapy. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Dose escalation will not occur until all patients within a cohort have been observed for 28 days from day 1 of therapy. Patients are followed until death.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Victoria
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Parkville, Victoria, Australia, 3052
- Royal Children's Hospital
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Western Australia
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Perth, Western Australia, Australia, 6001
- Princess Margaret Hospital for Children
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Hopital Sainte Justine
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Montreal, Quebec, Canada, H3H 1P3
- McGill University Health Center - Montreal Children's Hospital
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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California
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Duarte, California, United States, 91010
- City of Hope National Medical Center
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La Jolla, California, United States, 92093-0658
- University of California San Diego Cancer Center
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Los Angeles, California, United States, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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Los Angeles, California, United States, 90027-0700
- Children's Hospital Los Angeles
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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San Francisco, California, United States, 94143-0128
- UCSF Cancer Center and Cancer Research Institute
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Stanford, California, United States, 94305-5408
- Stanford University Medical Center
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District of Columbia
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Washington, District of Columbia, United States, 20010-2970
- Children's National Medical Center
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Florida
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Gainesville, Florida, United States, 32610-0296
- University of Florida Health Science Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, United States, 60614
- Children's Memorial Hospital, Chicago
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Chicago, Illinois, United States, 60611-3013
- Robert H. Lurie Comprehensive Cancer Center, Northwestern University
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Indiana
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Indianapolis, Indiana, United States, 46202-5289
- Indiana University Cancer Center
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Kansas
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Kansas City, Kansas, United States, 66160-7357
- University of Kansas Medical Center
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02111
- Boston Floating Hospital Infants and Children
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Michigan
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Ann Arbor, Michigan, United States, 48109-0752
- University of Michigan Comprehensive Cancer Center
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Detroit, Michigan, United States, 48201
- Children's Hospital of Michigan
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota Cancer Center
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Cancer Center
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Mississippi
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Jackson, Mississippi, United States, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Kansas City, Missouri, United States, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, United States, 63104
- Cardinal Glennon Children's Hospital
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, United States, 08901
- Cancer Institute of New Jersey
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New York
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Buffalo, New York, United States, 14263-0001
- Roswell Park Cancer Institute
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, United States, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
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New York, New York, United States, 10032
- Columbia Presbyterian Hospital
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Syracuse, New York, United States, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke Comprehensive Cancer Center
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Ohio
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Cincinnati, Ohio, United States, 45229-3039
- Children's Hospital Medical Center - Cincinnati
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Columbus, Ohio, United States, 43205-2696
- Children's Hospital of Columbus
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73190
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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South Carolina
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Charleston, South Carolina, United States, 29425-0721
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Texas
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Dallas, Texas, United States, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, United States, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Houston, Texas, United States, 77030-2399
- Texas Children's Cancer Center
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San Antonio, Texas, United States, 78284-7811
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, United States, 84113
- Primary Children's Medical Center
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Washington
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Seattle, Washington, United States, 98105
- Children's Hospital and Regional Medical Center - Seattle
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West Virginia
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Huntington, West Virginia, United States, 25704
- Veterans Affairs Medical Center - Huntington
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Wisconsin
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Madison, Wisconsin, United States, 53792-6164
- University of Wisconsin Comprehensive Cancer Center
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Milwaukee, Wisconsin, United States, 53226
- Midwest Children's Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Histologically or cytologically proven recurrent or refractory solid tumors
- No leukemia
- Patients with brain tumors are not eligible until the first 2 patients at each dose level are evaluable for toxicity
PATIENT CHARACTERISTICS:
- Age: 21 and under
- Performance status: Karnofsky 50-100% Lansky play scale 50-100% (for infants)
- Life expectancy: At least 8 weeks
- Absolute neutrophil count at least 1,000/mm3
- Hemoglobin at least 9 g/dL
- Platelet count at least 75,000/mm3
- Bilirubin less than 1.5 mg/dL
- SGPT less than 5 times upper limit of normal
- Creatinine normal for age OR GFR at least 70 mL/min
- Cardiac shortening fraction at least 27% OR institutional normal OR cardiac ejection fraction greater than 50% OR institutional normal
- Neurologic deficits in patients with CNS tumors must be stable for at least 2 weeks
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after the study
- No uncontrolled infection
PRIOR CONCURRENT THERAPY:
- At least 1 week since prior growth factor therapy and recovered
- At least 6 months since prior bone marrow transplantation and no evidence of graft versus host disease
- At least 2 weeks since prior myelosuppressive chemotherapy and recovered
- At least 6 weeks since prior nitrosourea and recovered
- At least 2 weeks on stable dexamethasone for patients with CNS tumors
- No concurrent chemotherapy
- At least 2 weeks since prior palliative radiotherapy (small port)
- At least 6 months since prior substantial bone marrow radiation
- At least 6 months since total abdominal, pelvic, chest, mantle, and Y ports radiotherapy
- No other concurrent anticancer therapy or investigational agents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
If the dose limiting toxicity is myelosuppression in stratum 1, then stratum 1 is closed and stratum 2 opens. Stratum 2 consists of the following: patients receiving no more than 2 prior chemotherapy regimens; patients who have not received prior central axis radiation or bone marrow transplantation; and patients with no known bone marrow involvement. Patients receive intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days. The course is repeated every 28 days unless disease progression or unacceptable toxic effects are observed. Patients with stable or responding disease may receive up to 1 year of therapy. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Dose escalation will not occur until all patients within a cohort have been observed for 28 days from day 1 of therapy. Patients are followed until death. |
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Gail C. Megason, MD, University of Mississippi Cancer Clinic
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-01838
- POG-9772
- CDR0000066359 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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