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A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study

Phase 1
21 Years
Not Enrolling
Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study


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

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.

Inclusion Criteria


- 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


- 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

- No uncontrolled infection


- 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

- No other concurrent anticancer therapy or investigational agents

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Gail C. Megason, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Mississippi Cancer Clinic


United States: Food and Drug Administration

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Stanford University Medical Center Stanford, California  94305-5408
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago, Illinois  60611
Children's Hospital of Michigan Detroit, Michigan  48201
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
State University of New York - Upstate Medical University Syracuse, New York  13210
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Boston Floating Hospital Infants and Children Boston, Massachusetts  02111
University of Florida Health Science Center Gainesville, Florida  32610-0296
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Dana-Farber Cancer Institute Boston, Massachusetts  02115
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Hackensack University Medical Center Hackensack, New Jersey  07601
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital Medical Center - Cincinnati Cincinnati, Ohio  45229-3039
Children's Hospital of Columbus Columbus, Ohio  43205-2696
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Cook Children's Medical Center - Fort Worth Fort Worth, Texas  76104
Texas Children's Cancer Center Houston, Texas  77030-2399
Columbia Presbyterian Hospital New York, New York  10032
Children's Memorial Hospital, Chicago Chicago, Illinois  60614
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
City of Hope National Medical Center Los Angeles, California  91010
Veterans Affairs Medical Center - Huntington Huntington, West Virginia  25704