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 Completed 12 to 30 NCI-93-C-0166

Objectives

I.  Determine the MTD of somatuline administered as a continuous infusion in 
patients with osteosarcoma.

II.  Determine the dose of somatuline that results in maximal suppression of 
circulating serum insulin-like growth factor-I levels (i.e., the biologically 
effective dose or BED) in these patients.

III.  Determine the maximum degree of inhibition of arginine-stimulated growth 
hormone (GH) secretion by somatuline.

IV.  Determine the toxicities of prolonged somatuline administration.

V.  Develop pilot/feasibility data for a Phase III study of somatuline as 
adjuvant treatment for osteosarcoma.

Entry Criteria

Disease Characteristics:

Biopsy-proven osteosarcoma in one of the following categories:
  Active tumor with no available standard therapy options
  Metastatic tumor at diagnosis and NED following therapy
  Disease-free on CT following thoracotomy for recurrent
     disease

Measurable disease not required

Prior/Concurrent Therapy:

Recovery from the acute effects of prior antineoplastic therapy
required

Biologic therapy:
  Not specified

Chemotherapy:
  At least 4 weeks since chemotherapy

Endocrine therapy:
  Not specified

Radiotherapy:
  At least 4 weeks since radiotherapy

Surgery:
  Not specified

Patient Characteristics:

Age:
  12 to 30

Performance status:
  ECOG 0-2

Life expectancy:
  At least 8 weeks

Hematopoietic:
  (within 7 days prior to therapy)
  ANC greater than 1,500
  Platelets greater than 100,000

Hepatic:
  (within 7 days prior to therapy)
  Bilirubin less than 2 x ULN

Renal:
  (within 7 days prior to therapy)
  Creatinine no greater than 2.0 mg/dl OR
  Creatinine clearance at least 40 ml/min/1.73 sqm

Other:
  HIV seronegative within 6 months of study entry
  Thyroid function normal
  No history of insulin-dependent diabetes mellitus or current
     insulin requirement (fasting morning blood glucose less
     than 150 mg/dl)
  Negative serum or urine beta HCG required in fertile women
  Appropriate contraception required as indicated
  Patient, parent, or guardian must be capable of caring for
     externalized central venous line and maintaining portable
     continuous infusion pump device (subcutaneously implanted
     device is unacceptable)

Expected Enrollment

Up to 30 patients will be enrolled over 2 years.  If none of the first 10 
patients treated over the first 3 dose levels achieves a greater than 50% 
reduction in IGF-I level, the study will be terminated.  If the MTD occurs 
prior to establishing a biologically effective dose (BED) or if the BED is 
established after 2 dose escalations, accrual will close.

Outline

Nonrandomized study.

Somatostatin Analogue Therapy.  Somatuline.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Leonard Wexler, MD, Protocol chair		Ph: 212-639-7990; 800-525-2225 Email: wexlerl@mskcc.org