A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma
Status:
Completed
Trial end date:
2000-09-01
Target enrollment:
Participant gender:
Summary
The suppression of IGF-I and growth hormone may significantly alter the pathobiology of
osteosarcoma. SMS 201-955 pa LAR is a long acting analog of Somatostatin which inhibits the
pituitary release of growth hormone, reducing levels of circulating IGF-I . Additional data
on tamoxifen usage has also demonstrated a reduction in circulating IGF-I levels. The degree
of suppression of IGF-I and growth hormone will be determined at two dose levels of SMS
291-955 pa LAR. Tamoxifen will be added to two of the cohorts to determine if the additive
effects of tamoxifen and SMS 201-955 pa LAR will lead to additional reduction of circulating
IGF-I and growth hormone levels.
Arginine-stimulated GH tests to assess levels of growth hormone in the blood will be
administered pre-treatment evaluation up to three times, one time on weeks 2, 8, 16, 28, 40,
52, and one month post last dose of SMS 201-955 pa LAR.
The four cohorts for this study will receive 60 or 90 mg SMS 201-955 pa LAR injectable every
four weeks for up to 52 weeks. Two of the cohorts will receive 10 mg Tamoxifen on a daily
basis.