A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Must have been diagnosed with osteosarcoma by the age of 25 years.
Patient must have a biopsy proven osteosarcoma and either: a) active tumor with no available standard therapy options; b) metastatic osteosarcoma at diagnosis, has completed therapy and has no evidence of active disease; or, c) is status-post any surgery for recurrent osteosarcoma, either local or metastatic recurrence, and is free of disease by CT scan.
Measurable disease not required.
Patients with serum creatinine <e; 2.0 mg/dL or creatinine clearance >e; 40 ml/min per 1.73m(2) (if serum creatinine is >e; 2.0 mg/dL).
Patients with normal thyroid function.
Patients with total bilirubin, SGOT and SGPT < twice the upper limit of normal.
Patients with normal direct bilirubin only if total direct bilirubin is abnormal.
Patients with bone marrow criteria: ANC>1500/mm(3) and platelet count >100,000/mm(3).
Patients without a history of insulin-dependent diabetes mellitus or current insulin requirement. Fasting morning blood glucose <150 mg/dL.
Patients with ECOG performance status of 0, 1 or 2 and a life expectancy of at least 8 weeks.
Patients not on chemotherapy or radiation therapy within the past 2 weeks and recovered from the acute side effects of prior anti-neoplastic therapy.
Patients with documented negative HIV serology within the past 6 months.
Post-menarcheal patients must have documented negative urine and serum pregnancy test (B-HCG); when indicated, patient must be willing to take oral contraceptives or other appropriate contraceptives to avoid pregnancy during the period of treatment.
Patient, parent or guardian must give informed consent.
No pregnant or lactating women.
No women of child-bearing potential who are unable or unwilling to use appropriate contraceptives during the period of treatment.
No patients with uncorrected hypothyroidism.
No patients with insulin-dependent diabetes mellitus or fasting blood glucose >e; 150 mg/dL.
No patients with HIV infection.
No patients with a history of thromboembolic events who require prophylaxis for thromboembolic events with anticoagulants once entry into Cohort III has begun.
Patients with a history of symptomatic gallbladder disease must have had a cholecystectomy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Kappel CC, Velez-Yanguas MC, Hirschfeld S, Helman LJ. Human osteosarcoma cell lines are dependent on insulin-like growth factor I for in vitro growth. Cancer Res. 1994 May 15;54(10):2803-7.
- Pollak M, Sem AW, Richard M, Tetenes E, Bell R. Inhibition of metastatic behavior of murine osteosarcoma by hypophysectomy. J Natl Cancer Inst. 1992 Jun 17;84(12):966-71. doi: 10.1093/jnci/84.12.966.
- Malaab SA, Pollak MN, Goodyer CG. Direct effects of tamoxifen on growth hormone secretion by pituitary cells in vitro. Eur J Cancer. 1992;28A(4-5):788-93. doi: 10.1016/0959-8049(92)90116-j.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplastic Processes
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Sarcoma
- Neoplasm Metastasis
- Osteosarcoma
- Physiological Effects of Drugs
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Bone Density Conservation Agents
- Estrogen Antagonists
- Selective Estrogen Receptor Modulators
- Estrogen Receptor Modulators
- Tamoxifen
Other Study ID Numbers
- 950119
- 95-C-0119
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