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 Closed 18 and over UPCC-3993 NCI-V94-0531

Objectives

I.  Assess the effects of clofibrate on human tumor cell 
differentiation/maturation by microscopic and immunohistochemical staining.

II.  Examine the pattern and degree of gene bcl-2 and proliferating cell 
nuclear antigen expression in these cells.

III.  Evaluate antitumor response to clofibrate in patients with advanced 
cancer.

Entry Criteria

Disease Characteristics:

Metastatic or locally recurrent cancer that cannot be cured or
palliated by conventional therapy
  Leukemia specifically excluded

Tumors likely to express bcl-2 required, e.g.:
  Gastrointestinal carcinoma
  Follicular non-Hodgkin's lymphoma
  Metastatic melanoma

Accessible tumors for easy and safe biopsy required, e.g.:
  Lymph nodes
  Subcutaneous masses
  Locally recurrent rectal cancers

Measurable or evaluable disease required

--Prior/Concurrent Therapy-

Prior and concurrent treatment not specified

Patient Characteristics:

Age:
  18 and over

Performance status:
  ECOG 0-3

Life expectancy:
  At least 2 months

Hematopoietic:
  WBC at least 4,000
  AGC at least 2,000
  Platelets at least 100,000

Hepatic:
  Bilirubin less than 2.0 mg/dl

Renal:
  Creatinine no greater than 2.0 mg/dl

Other:
  No cholelithiasis or cholecystitis within 1 year prior to
     entry
  No requirement for warfarin
  No significant medical or psychiatric illness that could
     compromise treatment or preclude informed consent
  No active infection
  No pregnant or nursing women
  Effective contraception required of fertile patients

Blood/body fluid analyses to determine eligibility completed
within 14 days prior to registration; imaging and physical
studies to document measurable or evaluable disease completed
within 28 days prior to registration; other imaging studies
completed within 42 days prior to registration

Expected Enrollment

10 patients with gastrointestinal cancer and 10 patients with other cancers 
will be entered in this study.

Outline

Differentiation Therapy.  Clofibrate, NSC-79389.

Trial Contact Information

Trial Lead Organizations

Abramson Cancer Center of the University of Pennsylvania

David Vaughn, MD, Protocol chair		Ph: 215-349-8140