Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme


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

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Trial Information

Open Label Phase II Study On Glufosfamide Administered As A 60 Minute Infusion Every 3 Weeks In Recurrent Glioblastoma Multiforme


OBJECTIVES: I. Determine the activity of glufosfamide, in terms of objective response rate
and/or progression-free survival at 6 months, in patients with recurrent glioblastoma
multiforme. II. Determine the duration of objective response in patients treated with this
regimen. III. Determine the toxic effects and pharmacokinetic profile of this regimen in
these patients.

OUTLINE: This is a multicenter study. Patients receive glufosfamide IV over 60 minutes on
day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable
toxicity. Patients with stable disease receive treatment for a minimum of 6 months or until
progression. Patients with an objective complete response receive a maximum of 2 additional
courses of treatment after confirmation of response. Patients are followed every 6 weeks
until progression.

PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed glioblastoma multiforme
Recurrent disease by CT scan or MRI At least 1 bidimensionally measurable target lesion at
least 2 cm in the largest diameter

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3 Platelet count at least
100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) Alkaline
phosphatase no greater than 2.5 times ULN AST and ALT no greater than 2.5 times ULN Renal:
Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min
Cardiovascular: Cardiac function normal No history of ischemic heart disease within the
past 6 months 12 lead ECG normal Other: No other prior or concurrent malignancy except
cone biopsied cervical cancer or adequately treated basal cell or squamous cell skin
cancer No unstable systemic disease No active uncontrolled infection No psychological,
familial, sociological, or geographical condition that would preclude study Not pregnant
or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent prophylactic growth factors
(e.g., filgrastim (G-CSF)) Chemotherapy: No more than 1 prior chemotherapy regimen as
adjuvant therapy or for recurrent disease At least 6 weeks since prior chemotherapy
Endocrine therapy: Stable or decreasing dose of corticosteroids for at least 1 week prior
to study Radiotherapy: At least 3 months since prior radiotherapy to the brain No prior
high-dose radiotherapy (more than 65 Gy), stereotactic radiosurgery, or internal
radiotherapy unless the disease recurrence is histologically confirmed Surgery: No prior
surgery (except biopsy) for recurrent brain tumor At least 3 months since prior surgery
for primary brain tumor Other: No other concurrent anticancer agents No other concurrent
investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Martin J. van Den Bent, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-16994G-26002

NCT ID:

NCT00014300

Start Date:

January 2001

Completion Date:

Related Keywords:

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

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