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Metastatic OsteosarcomaPhase 2NCT01886105

Combination of External Beam Radiotherapy With 153Sm-EDTMP to Treat High Risk Osteosarcoma

A Phase 2 study testing Sm-EDTMP, Autologous Stem Cell Infusion and External Beam Radiotherapy in people with Metastatic Osteosarcoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy. Read more about this study

Who is it for?
Ages 10 to 65 years
Conditions the study is for
Metastatic Osteosarcoma
What is being tested?
Sm-EDTMP, Autologous Stem Cell Infusion and External Beam Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
19 Aug 2013to 11 Jun 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 10 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must be between 13 and 65 years of age, inclusive
  • Must have unresectable primary tumor or metastases
  • Must have measurable disease that is demonstrated by positive Tc-99m Bone Scan. Not all lesions must be positive on bone scan.
  • Creatinine clearance >70ml/min/1.73m2
  • ANC >500/mm3
  • Platelets >50,000/mm3
Show all 9Show fewer
  • Life expectancy > 8 weeks
  • Karnofsky performance status >50%
  • Stem cell product collected prior to the infusion of Samarium must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry.

Who cannot join

  • Patient may not be pregnant or breastfeeding.
  • Patients who have received prior radiotherapy to all areas of current active disease are not eligible.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

Other trials in United States

About this study

The primary goal of this study will be to examine tumor response after radiation treatment via a combination of Samarium-153 EDTMP and external beam radiotherapy.

Read the detailed description

Samarium tracer infusion of 1 mCi/kg administered. SPECT images wil be used to determine the distribution of dose delivered to the tumor. This information will be used to determine target doses of external beam radiotherapy. The treatment infusion of Samarium, 30 mCi/kg, will be administered and dosimetry will confirm total dose delivered, and information will be used to finalize doses of external beam radiotherapy. Approximately 14 days after treatment infusion, autologous stem cells infusion is administered. Radiotherapy will be delivered according to the judgement of the treating radiation oncologist.

Being tested
Sm-EDTMP, Autologous Stem Cell Infusion, External Beam Radiotherapy
Keywords
Osteosarcoma, Osteogenic Sarcoma, Sarcoma, Bone Cancer
Medical subject headings
Osteosarcoma, Sarcoma, Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sm-EDTMPDrug

    Also called Samarium, 153Sm-EDTMP

    Subjects receive a "tracer" infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post "tracer" infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. "Tracer" activity will be applied to development of the external beam radiation (EBT) planning. Second "treatment" infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg.

  • Autologous Stem Cell InfusionOther

    Also called Stem Cells

    Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP.

  • External Beam RadiotherapyRadiation

    Also called Radiation

    The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.

    After the "treatment" infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary.

Study groups in NCT01886105
Study groupRoleWhat they receive
SmEDTMP/Autologous Stem Cell Infusion/RTExperimentalDAY 1 Tracer dose 153Sm-EDTMP administration (1 mCi/kg) SPECT/High-resolution CT at 4 hours. SPECT/CT (low resolution) at 24 and 48 hrs DAY 7 Individualized treatment dose 153Sm-EDTMP administration (max 30 mCi/kg) SPECT scans at 4, 24 and 48 hours DAY 21 (2 weeks following treatment dose) Auto-Stem cell infusion DAY 40 (approx. two weeks after stem cell rescue) Initiate EBT upon count recovery 1 MONTH following completion of all therapy Response assessment with repeat imaging (CT/MRI, Tc-99m bone scan) 18F-MISO/FDG PET
Receives: Drug: Sm-EDTMP; Other: Autologous Stem Cell Infusion; Radiation: External Beam Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Treated Participants With 6-month Progression Free Survival

    Percentage of patients with high-risk osteogenic sarcoma, treated with high-dose Samarium-153 EDTMP and external beam radiotherapy, without progression at 6 months.

    Measured: 6 months post-intervention

Secondary outcomes (1)

  1. Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity

    Number of patients experiencing any Grade 3-4 toxicity, as defined by CTCAE v4.0 and RTOG Cooperative Group Common Toxicity Criteria, during the trial intervention and follow-up.

    Measured: Up to 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2013 (estimated)
  2. Study start19 Aug 2013
  3. Primary completion11 Dec 2015
  4. Study completion11 Jun 2017

Why it stopped: Low accrual and loss of funding

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01886105
Sponsor's protocol ID
J1322
Other IDs
NA_00075773
Status last verified
Oct 2019
First submitted
4 Jun 2013
Last updated
29 Oct 2019
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • FRANCIS KC, PHILLIPS R, NICKSON JJ, WOODARD HQ, HIGINBOTHAM NL, COLEY BL. Massive preoperative irradiation in the treatment of osteogenic sarcoma in children; a preliminary report. Am J Roentgenol Radium Ther Nucl Med. 1954 Nov;72(5):813-8. No abstract available.

    PubMed 13207496

  • Jenkin RD, Allt WE, Fitzpatrick PJ. Osteosarcoma. An assessment of management with particular reference to primary irradiation and selective delayed amputation. Cancer. 1972 Aug;30(2):393-400. doi: 10.1002/1097-0142(197208)30:23.0.co;2-2. No abstract available.

    PubMed 4506001

  • Kang CH, Ferguson-Miller S, Margoliash E. Steady state kinetics and binding of eukaryotic cytochromes c with yeast cytochrome c peroxidase. J Biol Chem. 1977 Feb 10;252(3):919-26.

    PubMed 14138

  • LEE ES, MACKENZIE DH. OSTEOSARCOMA. A STUDY OF THE VALUE OF PREOPERATIVE MEGAVOLTAGE RADIOTHERAPY. Br J Surg. 1964 Apr;51:252-74. doi: 10.1002/bjs.1800510405. No abstract available.

    PubMed 14138245

  • Singh A, Holmes RA, Farhangi M, Volkert WA, Williams A, Stringham LM, Ketring AR. Human pharmacokinetics of samarium-153 EDTMP in metastatic cancer. J Nucl Med. 1989 Nov;30(11):1814-8.

    PubMed 2478681

  • Winderen M, Kjonniksen I, Fodstad O. Pronounced therapeutic effect of samarium 153-ethylenediaminetetramethylene phosphonate in an orthotopic human osteosarcoma tibial tumor model. J Natl Cancer Inst. 1995 Feb 1;87(3):221-2. doi: 10.1093/jnci/87.3.221. No abstract available.

    PubMed 7707409

  • Lattimer JC, Corwin LA Jr, Stapleton J, Volkert WA, Ehrhardt GJ, Ketring AR, Anderson SK, Simon J, Goeckeler WF. Clinical and clinicopathologic response of canine bone tumor patients to treatment with samarium-153-EDTMP. J Nucl Med. 1990 Aug;31(8):1316-25.

    PubMed 2384798

  • Milner RJ, Dormehl I, Louw WK, Croft S. Targeted radiotherapy with Sm-153-EDTMP in nine cases of canine primary bone tumours. J S Afr Vet Assoc. 1998 Mar;69(1):12-7. doi: 10.4102/jsava.v69i1.802.

    PubMed 9646255

  • Aas M, Moe L, Gamlem H, Skretting A, Ottesen N, Bruland OS. Internal radionuclide therapy of primary osteosarcoma in dogs, using 153Sm-ethylene-diamino-tetramethylene-phosphonate (EDTMP). Clin Cancer Res. 1999 Oct;5(10 Suppl):3148s-3152s.

    PubMed 10541356

  • Turner JH, Claringbold PG, Hetherington EL, Sorby P, Martindale AA. A phase I study of samarium-153 ethylenediaminetetramethylene phosphonate therapy for disseminated skeletal metastases. J Clin Oncol. 1989 Dec;7(12):1926-31. doi: 10.1200/JCO.1989.7.12.1926.

    PubMed 2585026

  • Turner JH, Claringbold PG. A phase II study of treatment of painful multifocal skeletal metastases with single and repeated dose samarium-153 ethylenediaminetetramethylene phosphonate. Eur J Cancer. 1991;27(9):1084-6. doi: 10.1016/0277-5379(91)90297-q.

    PubMed 1720321

  • Collins C, Eary JF, Donaldson G, Vernon C, Bush NE, Petersdorf S, Livingston RB, Gordon EE, Chapman CR, Appelbaum FR. Samarium-153-EDTMP in bone metastases of hormone refractory prostate carcinoma: a phase I/II trial. J Nucl Med. 1993 Nov;34(11):1839-44.

    PubMed 8229221

  • Bruland OS, Skretting A, Solheim OP, Aas M. Targeted radiotherapy of osteosarcoma using 153 Sm-EDTMP. A new promising approach. Acta Oncol. 1996;35(3):381-4. doi: 10.3109/02841869609101655.

    PubMed 8679270

  • Franzius C, Bielack S, Flege S, Eckardt J, Sciuk J, Jurgens H, Schober O. High-activity samarium-153-EDTMP therapy followed by autologous peripheral blood stem cell support in unresectable osteosarcoma. Nuklearmedizin. 2001 Dec;40(6):215-20.

    PubMed 11797510

  • Anderson PM, Wiseman GA, Dispenzieri A, Arndt CA, Hartmann LC, Smithson WA, Mullan BP, Bruland OS. High-dose samarium-153 ethylene diamine tetramethylene phosphonate: low toxicity of skeletal irradiation in patients with osteosarcoma and bone metastases. J Clin Oncol. 2002 Jan 1;20(1):189-96. doi: 10.1200/JCO.2002.20.1.189.

    PubMed 11773169

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sm-EDTMP, Autologous Stem Cell Infusion and External Beam Radiotherapy in people with Metastatic Osteosarcoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Oct 2019. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Percentage of Treated Participants With 6-month Progression Free Survival (time frame: 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01886105, which also lists 26 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 29 Oct 2019.

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