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A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma

2014-08-27 03:59:35 | BioPortfolio

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.

Description

Osteosarcoma is the most common primary bone malignancy in childhood and adolescence. Its peak age of onset has suggested a possible contribution to the pathogenesis of the tumor by the endogenous hormonal milieu, which accompanies the adolescent growth spurt. In support of this, recent in vitro and in vivo laboratory investigators suggest that Insulin-like growth factor I (IGF I) may play an important role in the pathobiology of osteosarcoma. Somatostatin (and its longer-acting analogues) directly inhibits the pituitary release of growth hormone, thereby indirectly reducing the level of circulating IGF I. Other data have also demonstrated that the anti-estrogen, tamoxifen, significantly reduced circulating IGF I levels. We propose to administer the long acting somatostatin analog, OncoLAR® (Registered Trademark), alone and in combination with tamoxifen in patients with osteosarcoma. The degree of suppression of both circulating IGF I and growth hormone levels will be determined at two dose levels of OncoLAR® (Registered Trademark) alone and in combination with tamoxifen to determine whether the addition of tamoxifen to OncoLAR® (Registered Trademark) leads to significant additional reduction in circulating IGF I and growth hormone levels.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Conditions

Neoplasm Metastasis

Intervention

OncoLAR® (Registered Trademark), tamoxifen

Location

National Cancer Institute (NCI)
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:59:35-0400

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Medical and Biotech [MESH] Definitions

The transfer of a neoplasm from one organ or part of the body to another remote from the primary site.

One of the SELECTIVE ESTROGEN RECEPTOR MODULATORS with tissue-specific activities. Tamoxifen acts as an anti-estrogen (inhibiting agent) in the mammary tissue, but as an estrogen (stimulating agent) in cholesterol metabolism, bone density, and cell proliferation in the ENDOMETRIUM.

Transfer of a neoplasm from its primary site to lymph nodes or to distant parts of the body by way of the lymphatic system.

Abnormal growths of tissue that follow a previous neoplasm but are not metastases of the latter. The second neoplasm may have the same or different histological type and can occur in the same or different organs as the previous neoplasm but in all cases arises from an independent oncogenic event. The development of the second neoplasm may or may not be related to the treatment for the previous neoplasm since genetic risk or predisposing factors may actually be the cause.

Intercellular signaling peptides that were originally characterized by their ability to suppress NEOPLASM METASTASIS. Kisspeptins have since been found to play an important role in the neuroendocrine regulation of REPRODUCTION.

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