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	Completed	18 and over		MSKCC-87094 NCI-V88-0389

Objectives

I.  Assess the therapeutic efficacy of a somatostatin analogue, Sandostatin 
(SMS 201-995), in the treatment of patients with chondrosarcoma and refractory 
osteosarcoma.

II.  Evaluate the toxicity of SMS 201-995 in this patient population.

Entry Criteria

Disease Characteristics:

Low- or intermediate-grade chondrosarcoma, mesenchymal
chondrosarcoma, or osteogenic sarcoma that is metastatic or
unresectable

  Potentially resectable disease that is deemed unsuitable for
  surgery because of the patient's general medical condition is
  also eligible

  Large (greater than 10 cm), resectable primary low- or
  intermediate-grade chondrosarcoma and resectable metastatic
  chondrosarcoma or osteosarcoma may be treated preoperatively

Mesenchymal chondrosarcoma or osteosarcoma must be refractory
to chemotherapy or patient must be medically unfit for
conventional chemotherapy

Measurable disease required, e.g.:

  Palpable tumor mass
  Parenchymal pulmonary mass on chest x-ray
  Discrete tumor mass on CT, ultrasound, or MRI

  Previously irradiated lesions are not considered measurable

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  See Disease Characteristics

Endocrine therapy:
  Not specified

Radiotherapy:
  Not specified

Surgery:
  See Disease Characteristics

Patient Characteristics:

Age:
  18 and over

Performance status:
  50-100%

Hematopoietic:
  WBC at least 3,000
  Platelets at least 100,000

Hepatic:
  Bilirubin no greater than 1.5 mg/dl

Renal:
  Creatinine no greater than 2.5 mg/dl

Other:
  No pregnant women

Expected Enrollment

If there are no major responses in the first 15 patients treated, the study 
will be terminated.  If 1 or 2 major responses are seen in the first 15 
patients, 5 additional patients will be entered for a total of 20; if there 
are at least 3 major responses in the first 15 patients, accrual will continue 
to a total of 30 patients.

Outline

Nonrandomized study.

Single-Agent Somatostatin Analogue Therapy.  Octreotide, Sandostatin, SMS 
201-995.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Ephraim Casper, MD, Protocol chair		Ph: 908-542-3000 Email: caspere@mskcc.org