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

Alternate Title

Aminocamptothecin Followed by Radiation Therapy in Treating Adults With Glioblastoma Multiforme

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CCF-IRB-1104 NCI-T94-0166D, T94-0166

Objectives

I.  Assess the response rate of patients with glioblastoma multiforme to 
aminocamptothecin.

II.  Correlate antitumor responses with topoisomerase I activity in tumor 
specimens.

Entry Criteria

Disease Characteristics:

Histologically proven glioblastoma multiforme

Tumor measurable and contrast-enhancing on MRI/CT

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  Steroid dose stable for at least 1 week prior to therapy

Radiotherapy:
  No prior radiotherapy to the brain

Surgery:
  More than 21 days since surgery requiring general anesthesia

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-2

Life expectancy:
  At least 12 weeks

Hematopoietic:
  AGC at least 1,500
  Platelets at least 100,000
  Hb at least 9.0 g/dl

Hepatic:
  Bilirubin no greater than 1.6 mg/dl
  SGOT no greater than 2 x normal

Renal:
  Creatinine no greater than 1.6 mg/dl

Other:
  No infection requiring systemic antibiotics within 21 days
  No medical contraindication to therapy
  No second malignancy within 5 years except:
     Nonmelanomatous skin cancer
     Carcinoma in situ of the cervix
  No pregnant or nursing women
  Effective contraception required of fertile women and sexually active men

Blood/body fluid analyses to determine eligibility and imaging studies and
physical exams for tumor measurement completed within 14 days prior to
registration; screening exams (other than blood/body fluid analyses) and
imaging studies of nonmeasurable disease or uninvolved organs completed
within 28 days prior to registration

Expected Enrollment

Up to 28 patients will be accrued over 12-18 months; if no response is seen in 
the first 15 patients, the study will close.

Outline

Therapy is interrupted or discontinued for radiotherapy (standard irradiation 
or stereotactic radiosurgery).  The following acronyms are used:
  9-AC   Aminocamptothecin, NSC-603071
  G-CSF  Granulocyte Colony Stimulating Factor (Amgen), NSC-614629

Single-Agent Chemotherapy.  9-AC.

Trial Contact Information

Trial Lead Organizations

Cleveland Clinic Foundation Hospital

David Peereboom, MD, Protocol chair		Ph: 216-445-6068; 800-862-7798 Email: peerebd@ccf.org