Neoplasm MetastasisPhase 1NCT00001436
A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma
A Phase 1 study testing OncoLAR® (Registered Trademark) and tamoxifen in people with Neoplasm Metastasis and Osteosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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 . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasm Metastasis, Osteosarcoma
- What is being tested?
- OncoLAR® (Registered Trademark) and tamoxifen
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 1995to Sep 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
About this study
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.
Read the detailed 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.
- Conditions
- Neoplasm Metastasis, Osteosarcoma
- Being tested
- OncoLAR® (Registered Trademark), tamoxifen
- Keywords
- Hormone Interactions, IGF-I, Metastatic, Pediatric, Recurrent
- Medical subject headings
- Neoplasm Metastasis, Osteosarcoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OncoLAR® (Registered Trademark)Drug
tamoxifenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMay 1995
- Study completionSep 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MetastasisStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001436
- Sponsor's protocol ID
- 950119
- Other IDs
- 95-C-0119
- Status last verified
- Apr 2000
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 8168113Pollak 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.
PubMed 1321252Malaab 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.
PubMed 1355980
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of OncoLAR® (Registered Trademark) (NSC 685403) With/Without Tamoxifen in Patients With Osteosarcoma
- ClinicalTrials.gov ID
- NCT00001436
- Acronym / sponsor ID
- 950119
- Conditions
- Neoplasm Metastasis, Osteosarcoma
- Keywords
- Hormone Interactions, IGF-I, Metastatic, Pediatric, Recurrent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 1995
- Study completion
- Sep 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OncoLAR® (Registered Trademark) | Drug | – |
| tamoxifen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8168113Kappel 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.
- Background: PubMed 1321252Pollak 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.
- Background: PubMed 1355980Malaab 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OncoLAR® (Registered Trademark) and tamoxifen in people with Neoplasm Metastasis and Osteosarcoma, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001436, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.