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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
N/A
21 Years
Not Enrolling
Both
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


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.

Inclusion Criteria


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

Type of Study:

Interventional

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

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01838

NCT ID:

NCT00003370

Start Date:

August 1998

Completion Date:

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Stanford University Medical CenterStanford, California  94305-5408
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Children's Hospital of MichiganDetroit, Michigan  48201
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
University of Florida Health Science CenterGainesville, Florida  32610-0296
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Hackensack University Medical CenterHackensack, New Jersey  07601
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Texas Children's Cancer CenterHouston, Texas  77030-2399
Columbia Presbyterian HospitalNew York, New York  10032
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
Primary Children's Medical CenterSalt Lake City, Utah  84113-1100
City of Hope National Medical CenterLos Angeles, California  91010
Veterans Affairs Medical Center - HuntingtonHuntington, West Virginia  25704