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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed under 21 at diagnosis NCI SJCRH-LY-SUL NCI-T91-0172D, T91-0172

Objectives

I.  Determine the MTD, dose-limiting toxicity, and quantitative and 
qualitative toxicities of sulofenur (LY186641) delivered on an intermittent 
schedule in pediatric patients with refractory solid tumors.

II.  Describe the antitumor effects of this drug.

III.  Determine the dosage to be used in a Phase II trial of LY186641.

IV.  Determine the pharmacokinetics of LY186641 and its metabolites in 
children by studying the bound and free plasma concentrations of LY186641 and 
the urinary concentrations of the parent compound and its metabolites.

Entry Criteria

Disease Characteristics:

Histologically confirmed malignant solid tumor that has failed
conventional surgery, radiotherapy, or chemotherapy, as
appropriate
  No leukemia
  No history of hematologic disorder

Measurable disease preferred but not required

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  See Disease Characteristics
  Recovery from toxicity of prior chemotherapy required

Endocrine therapy:
  Not specified

Radiotherapy:
  See Disease Characteristics

Surgery:
  See Disease Characteristics

Other:
  No concomitant drugs except analgesics
  No hypersensitivity to sulfa drugs
  No requirement for any of the following:
     Acetaminophen
     Nitrates
     Nitrites
     Benzocaine
     Lidocaine
     Chloroquine
     Primaquine
     Quinine
     Sulfamethoxazole
     Other sulfa drugs

Patient Characteristics:

Age:
  Under 21 at diagnosis

Performance status:
  ECOG 0-2

Life expectancy:
  At least 8 weeks

Hematopoietic:
  WBC greater than 2,000
  ANC greater than 2,000
  Platelets greater than 100,000 (if marrow is not involved
     with tumor)
  Hb greater than 10 g/dl
  Methemoglobin less than 0.75 g/dl (< 10% methemoglobin/10 g
     hemoglobin)

Hepatic:
  Bilirubin less than 1.5 mg/dl
  SGOT no more than 2 x normal
  PT normal
  G-6-PD normal

Renal:
  Creatinine less than 1.5 mg/dl OR
  Creatinine clearance more than 80 ml/min/1.73 sqm
  Urinalysis normal

Cardiovascular:
  No abnormalities on EKG
  Shortening fraction at least 25% on echocardiogram

Metabolic:
  Electrolytes (including calcium and phosphate) normal
  Blood sugar normal
  No diabetes

Nutritional:
  Weight greater than tenth percentile for age
  Albumin greater than 3 g/dl

Other:
  No infection

Expected Enrollment

3 to 6 patients will be accrued to each dose studied.

Outline

Nonrandomized study.

Single-Agent Chemotherapy.  Sulofenur, LY186641, NSC-645012.

Trial Contact Information

Trial Lead Organizations

St. Jude Children's Research Hospital

Charles Benton Pratt, MD, Protocol chair(Contact information may not be current)		Ph: 901-495-3442 Email: charles.pratt@stjude.org