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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	over 18	NCI	UCCRC-7484 NCI-T94-0147H, T94-0147

Objectives

I.  Evaluate the activity of aminocamptothecin (9-AC) in refractory or 
progressive malignant gliomas.

II.  Characterize the toxicity of 9-AC and determine the duration of response, 
time to progression, and survival.

III.  Characterize the pharmacokinetics and pharmacodynamics of 9-AC in 
patients treated on this study and similar studies involving patients with 
other tumor types.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed malignant glioma, including:
  Grade III/IV astrocytoma
  Anaplastic astrocytoma
  Grade IV ependymoma
  Recurrent oligodendroglioma
  Prior low-grade astrocytoma that has developed features of glioblastoma
     multiforme

Progressive disease following surgery and radiotherapy required by one of the
following:
  Histologic documentation
  Unequivocal evidence by CT or MRI
  Unequivocal clinical progression

Steroid dose stable for at least 7 days prior to entry

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  At least 4 weeks since chemotherapy (6 weeks since nitrosoureas)
  No more than 1 prior chemotherapy regimen allowed, e.g.:
     Adjuvant chemotherapy
     Chemotherapy concomitantly with radiotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy

Surgery:
  At least 2 weeks since major surgery

Patient Characteristics:

Age:
  18 and over

Performance status:
  CALGB 0-2

Life expectancy:
  At least 8 weeks

Hematopoietic:
  WBC at least 3,500
  AGC at least 1,500
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl (unless attributed to Gilbert's disease)
  SGOT no greater than 2 x normal
  Alkaline phosphatase no greater than 2 x normal

Renal:
  Creatinine no greater than 1.5 mg/dl

Other:
  No pregnant or nursing women
  Effective contraception required of fertile patients

Expected Enrollment

If at least 1 response is seen in the first 14 patients, an additional 26 
patients will be enrolled.  Accrual is expected to require 2 years.

Outline

Single-Agent Chemotherapy.  Aminocamptothecin, 9-AC, NSC-603071.

Trial Contact Information

Trial Lead Organizations

University of Chicago Cancer Research Center

Juan Garcia, MD, FACP, Protocol chair		Ph: 574-472-6400 Email: jgarcia923@aol.com