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

Alternate Title

Chemotherapy in Treating Patients With Refractory Astrocytoma or Glioblastoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	NABTT-9605 JHOC-NABTT-9605, NCI-T96-0086

Objectives

I.  Determine the maximum tolerated dose of phenylbutyrate in patients with 
refractory anaplastic astrocytoma or glioblastoma.

II.  Document any evidence of a therapeutic response in this patient 
population.

Entry Criteria

Disease Characteristics:

Histologically or cytologically proven glioblastoma or anaplastic astrocytoma
refractory to conventional therapy or for which no effective therapy is known

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 No chemotherapy within the past 28 days
 Recovered from toxic effects
 No prior sodium phenylacetate, phenylbutyrate, or antineoplaston therapy

Endocrine therapy:
 Concurrent dexamethasone or other steroids for control of CNS edema/cord     

  compression allowed
   Must be on stable dose for at least 1 week

Radiotherapy:
 No radiotherapy within the past 28 days
 Recovered from toxic effects

Surgery:
 No recent major surgery

Patient Characteristics:

Age:
 18 and over

Performance status:
 Karnofsky 60-100%

Life expectancy:
 Not specified

Hematopoietic:
 Absolute neutrophil count greater than 1500/mm3
 Platelet count greater than 75,000/mm3

Hepatic:
 Bilirubin less than 1.5 mg/dL
 Transaminases less than 4 times upper limit of normal

Renal:
 Creatinine less than 1.7 mg/dL

Cardiovascular:
 Must have adequate cardiac function
 No active congestive heart failure or uncontrolled hypertension
  
Other:
 Fertile patients must use effective contraception 2 weeks before, during and 

  3 months after study
 Not pregnant or nursing
 No autoimmune diseases such as systemic lupus erythematosus, scleroderma, or 

  other connective tissue illness
 No active infectious process, including HIV and viral hepatitis
 No active seizure disorders
 Normal GI function
 No dementia

Expected Enrollment

A maximum of 25 patients will be accrued for this study.

Outline

This is a dose escalation study.

All patients receive oral phenylbutyrate three times a day until documented 
tumor progression or Karnofsky performance status falls to 30%.

Four patients are treated at each dose level.  Dose escalation proceeds until 
the maximum tolerated dose (MTD) is determined.  The MTD is defined as the 
dose preceding that at which 2 or more patients experience dose limiting 
toxicity.

Patients are followed for at least 22 days after therapy, then every 2 months 
until death.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Michael Carducci, MD, Protocol chair		Ph: 410-614-3977 Email: carducci@welchlink.welch.jhu.edu