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ZD1839 FOR Treatment Of Recurrent Or Progressive Malignant Astrocytoma Or Glioblastoma And Recurrent Or Progressive Meningioma: A Phase II Study With A Phase I Component For Patients Receiving EIAEDs


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

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Trial Information

ZD1839 FOR Treatment Of Recurrent Or Progressive Malignant Astrocytoma Or Glioblastoma And Recurrent Or Progressive Meningioma: A Phase II Study With A Phase I Component For Patients Receiving EIAEDs


OBJECTIVES:

- Determine the maximum tolerated dose of gefitinib in patients with recurrent or
progressive supratentorial malignant gliomas or brain or spinal meningiomas receiving
enzyme-inducing antiepileptic drugs (EIAEDs). (Phase I of the study closed to accrual
as of 09/19/2003).

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

- Determine the pharmacokinetics of this drug in patients receiving EIAEDs.

- Determine the efficacy of this drug in terms of 6-month progression-free survival of
these patients.

- Determine the safety profile of the phase II dose of this drug in these patients.

OUTLINE: This is a multicenter, dose-escalation study. Patients are stratified according to
concurrent enzyme-inducing antiepileptic drugs (EIAEDs) (yes vs no) and disease type (for
phase II only) (benign meningioma vs malignant meningioma vs hemangiopericytoma vs
glioblastoma vs other anaplastic glioma). (Phase I closed to accrual as of 09/19/2003).

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients (who are receiving EIAEDs) receive escalating doses of gefitinib
until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose
preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting
toxicity.

Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A minimum of 30 patients will be accrued for the phase I portion of this
study within 10 months . (Phase I closed to accrual as of 09/19/2003). A total of 48
patients will be accrued for the phase II portion of this study within 6-8 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Histologically confirmed supratentorial malignant primary glioma

- Glioblastoma multiforme

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Anaplastic mixed oligoastrocytoma

- Malignant astrocytoma not otherwise specified

- Histologically confirmed or radiographically defined recurrent or progressive
brain or spinal meningioma, including base of skull or cavernous sinus
meningiomas

- Benign, malignant, or atypical

- May include neurofibromatosis type I or II

- Hemangiopericytoma allowed

- Recurrent or progressive disease by MRI or CT scan

- Evidence of true progressive disease by PET or thallium scan, MR spectroscopy,
or surgical documentation required if patient received prior interstitial
brachytherapy or stereotactic radiosurgery (to the target lesion for meningioma
and hemangiopericytoma)

- Steroid dosage must be stable for at least 5 days prior to scan

- No limitations on the number of prior surgeries, radiotherapy or chemotherapy
regimens, or radiosurgery treatments for patients with meningioma or
hemangiopericytoma and may include standard external beam radiotherapy, interstitial
brachytherapy, or gamma-knife radiosurgery in any combination

- Patients with glioma must have failed prior radiotherapy

- Original histology of low-grade glioma allowed if subsequent confirmation of
malignant glioma is made at time of recurrence

- Phase I (closed to accrual as of 09/19/2003):

- Prior treatment for no more than 3 prior relapses in patients with glioma

- Phase II:

- Measurable disease after prior surgical resection of recurrent or progressive
disease

- Prior treatment for no more than 2 prior relapses in patients with glioma

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 8 weeks

Hematopoietic:

- WBC at least 3,000/mm^3

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

- Platelet count at least 120,000/mm^3

- Hemoglobin at least 10 g/dL (transfusion allowed)

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT less than 1.5 times ULN

Renal:

- Creatinine less than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No significant cardiac risk factors within the past 6 months

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No gastrointestinal risk factors (e.g., active ulcerative colitis) within the past 6
months

- No active infection

- No concurrent disease that would obscure toxicity or dangerously alter drug
metabolism

- No other significant medical illness that would preclude study

- No other malignancy within the past 3 years except non-melanoma skin cancer or
carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 1 week since prior interferon or thalidomide

- No concurrent filgrastim (G-CSF)

Chemotherapy:

- See Disease Characteristics

- At least 2 weeks since prior vincristine

- At least 6 weeks since prior nitrosoureas

- At least 3 weeks since prior procarbazine

Endocrine therapy:

- At least 1 week since prior tamoxifen

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

Surgery:

- See Disease Characteristics

- At least 7 days since prior surgery for recurrent or progressive tumor and recovered

Other:

- Recovered from prior therapy

- No prior gefitinib or other epidermal growth factor receptor inhibitor

- At least 1 week since prior isotretinoin

- At least 1 week since other prior noncytotoxic agents (except radiosensitizers)

- At least 4 weeks since prior investigational agents

- Concurrent low-molecular weight heparin or warfarin for deep vein thrombosis or
pulmonary embolism allowed

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Safety Issue:

No

Principal Investigator

Frank S. Lieberman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Food and Drug Administration

Study ID:

NABTC-0001 CDR0000068984

NCT ID:

NCT00025675

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult meningioma
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult pilocytic astrocytoma
  • adult subependymoma
  • adult mixed glioma
  • adult meningeal hemangiopericytoma
  • adult grade III meningioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult grade I meningioma
  • adult grade II meningioma
  • Astrocytoma
  • Glioblastoma
  • Meningioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
NCI - Neuro-Oncology BranchBethesda, Maryland  20892-8200