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A Phase I/II Trial Of MGI114 For Treatment Of Patients With Recurrent Malignant Gliomas


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

A Phase I/II Trial Of MGI114 For Treatment Of Patients With Recurrent Malignant Gliomas


OBJECTIVES:

- Determine the maximum tolerated dose (MTD) of irofulven alone or combined with
anticonvulsants known to be metabolized by cytochrome P450 in patients with progressive
or recurrent high-grade anaplastic astrocytoma, anaplastic oligodendroglioma, or
glioblastoma multiforme.

- Assess the pharmacokinetics of this drug on this schedule and determine the effects of
P450-inducing anticonvulsants on the pharmacokinetics in these patients.

- Determine the response rate of patients treated with this drug administered at the MTD.

- Determine the duration of progression-free survival and overall survival of patients
treated with this drug.

- Determine the toxic effects of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
concurrent use of anticonvulsant drugs that induce cytochrome P450 (yes vs no drugs or
modest-induction drugs).

Patients receive irofulven IV over 30 minutes on days 1-4 or 1-5 (depending on
dose-escalation level). Courses repeat every 4 weeks in the absence of disease progression
or unacceptable toxicity.

Cohorts of 3-6 patients (per stratum) receive escalating doses of irofulven until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is
determined, additional patients are accrued to receive treatment with irofulven at the
recommended phase II dose.

Patients are followed at 1 week and then every 2 months thereafter.

PROJECTED ACCRUAL: Approximately 18 patients (9 per stratum) will be accrued for the phase I
portion of the study. Approximately 17-35 patients will be accrued for the phase II portion
of the study within 6-12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven malignant high-grade glioma that is progressive or recurrent
after radiotherapy and/or chemotherapy

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Glioblastoma multiforme

- Prior low-grade glioma that has progressed to high-grade glioma after radiotherapy
and/or chemotherapy allowed

- Measurable disease by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- Transaminases no greater than 2.5 times upper limit of normal

Renal:

- Creatinine no greater than 1.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No serious concurrent infection or medical illness that would preclude study therapy

- No other prior malignancy within the past 5 years except curatively treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast

- Mini mental score at least 15

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- No more than 2 prior chemotherapy regimens

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

- Maintained on a stable corticosteroid regimen for at least 5 days before and during
study

Radiotherapy:

- See Disease Characteristics

- At least 3 months since prior radiotherapy and recovered

Surgery:

- Recovered from prior surgery

Other:

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Steven S. Rosenfeld, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000068474

NCT ID:

NCT00012038

Start Date:

July 2001

Completion Date:

October 2003

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Henry Ford HospitalDetroit, Michigan  48202
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195