Search / Trial NCT00001436

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of July 14, 2024

Completed

Keywords

Hormone Interactions Igf I Metastatic Pediatric Recurrent

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 ci...

Gender

All

Eligibility criteria

  • 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 &lte; 2.0 mg/dL or creatinine clearance &gte; 40 ml/min per 1.73m(2) (if serum creatinine is &gte; 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 &gte; 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.

Attachments

readout_NCT00001436_2024-07-14.pdf

4.5 MB

NCT00001436_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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