Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

SU101 in Treating Patients with Recurrent Malignant Glioma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over Pharmaceutical / Industry MSKCC-95019 NCI-V95-0663

Objectives

I.  Assess the maximum tolerated dose of SU101 when given as a series of four 
weekly 24-hour infusions in patients with recurrent malignant glioma.

II.  Assess the pharmacokinetic/pharmacodynamic profile of this schedule of 
SU101 in these patients.

Entry Criteria

Disease Characteristics:

Radiologically and/or pathologically confirmed malignant glioma of any of the
following histologies:
  Anaplastic astrocytoma            Anaplastic ependymoma
  Glioblastoma multiforme           Anaplastic oligodendroglioma
  Anaplastic oligoastrocytoma

Recurrent disease with no accepted alternative therapy

No CNS lymphoma or CNS metastases secondary to unknown primary

Prior/Concurrent Therapy:

More than 4 weeks since any other investigational agent

Biologic therapy:
  At least 4 weeks since immunotherapy

Chemotherapy:
  At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or
  mitomycin)

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 50%-100%

Life expectancy:
  At least 12 weeks

Hematopoietic:
  WBC at least 3,000
  ANC at least 1,500
  Platelets at least 100,000
  Hemoglobin at least 9.0 g/dL

Hepatic:
  Bilirubin less than 1.5 times normal
  AST/ALT no greater than 3 times normal
  Alkaline phosphatase no greater than 3 times normal

Renal:
  Creatinine no greater than 2.0 mg/dL

Other:
  No allergy to etoposide
  No other medical or psychiatric contraindication to protocol therapy
  No history of second malignancy except:
     Basal cell skin carcinoma
     In situ carcinoma of the cervix
  No pregnant or nursing women
     Negative serum pregnancy test required of fertile women
  Effective contraception required of fertile patients

Mini-mental status exam within 24 hours prior to treatment
Blood/body fluid analyses within 7 days prior to treatment
Imaging/exams for tumor measurement within 28 days prior to registration
  (within 14 days if disease rapidly progressive)

Expected Enrollment

Up to 45 patients will be treated.

Outline

Single-Agent Chemotherapy.  SU101.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Mark Malkin, MD, Protocol chair(Contact information may not be current)		Ph: 212-639-6688; 800-525-2225 Email: malkinm@mskcc.org