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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



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University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
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Simmons Cancer Center - DallasDallas, Texas  75235-9154
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Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
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Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Texas Children's Cancer CenterHouston, Texas  77030-2399
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