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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00075773 | Other Identifier | JHM IRB |
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Low accrual and loss of funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Jazz Pharmaceuticals | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmEDTMP/Autologous Stem Cell Infusion/RT | Experimental | DAY 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sm-EDTMP | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 48 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Ladle, MD, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13207496 | Background | 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. | |
| 4506001 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SmEDTMP/Autologous Stem Cell Infusion/RT | 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 to be delivered according to the judgement of the treating radiation oncologist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Individual patients
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SmEDTMP/Autologous Stem Cell Infusion/RT | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 6 months post-intervention |
|
up to 4 months
No patients who enrolled on the trial survived longer than 4 months. Toxicities were graded according to CTCAE v4.0 and the RTOG Cooperative Group Common Toxicity Criteria, and attributable toxicities grade 3 or higher were recorded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SmEDTMP/Autologous Stem Cell Infusion/RT | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v4.0 | Non-systematic Assessment | Pain from tumor requiring admission for IV pain medications. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Non-systematic Assessment | Nausea grade 2 or greater |
The study had low enrollment - 4 patients. Those that did enroll had very late stage disease and the therapy provided on this trial was the last therapy given for all 4 patients. Of the patients that began therapy, only 1 completed planned therapy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian H. Ladle | Johns Hopkins University | 443-287-3534 | bladle@jhmi.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2017 | Sep 27, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012516 | Osteosarcoma |
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
Not provided
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| ID | Term |
|---|---|
| C061972 | samarium Sm-153 lexidronam |
| D012493 | Samarium |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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|
|
| Autologous Stem Cell Infusion | Other | Administered 14 days after "Treatment" infusion of Samarium-153 EDTMP. |
|
|
| External Beam Radiotherapy | 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. |
|
|
| 14138 | Background | 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. |
| 14138245 | Background | 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. |
| 2478681 | Background | 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. |
| 7707409 | Background | 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. |
| 2384798 | Background | 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. |
| 9646255 | Background | 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. |
| 10541356 | Background | 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. |
| 2585026 | Background | 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. |
| 1720321 | Background | 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. |
| 8229221 | Background | 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. |
| 8679270 | Background | 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. |
| 11797510 | Background | 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. |
| 11773169 | Background | 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. |
| 19338063 | Background | Loeb DM, Garrett-Mayer E, Hobbs RF, Prideaux AR, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Dose-finding study of 153Sm-EDTMP in patients with poor-prognosis osteosarcoma. Cancer. 2009 Jun 1;115(11):2514-22. doi: 10.1002/cncr.24286. |
| 20715156 | Background | Loeb DM, Hobbs RF, Okoli A, Chen AR, Cho S, Srinivasan S, Sgouros G, Shokek O, Wharam MD Jr, Scott T, Schwartz CL. Tandem dosing of samarium-153 ethylenediamine tetramethylene phosphoric acid with stem cell support for patients with high-risk osteosarcoma. Cancer. 2010 Dec 1;116(23):5470-8. doi: 10.1002/cncr.25518. Epub 2010 Aug 16. |
| 21448934 | Background | Ciernik IF, Niemierko A, Harmon DC, Kobayashi W, Chen YL, Yock TI, Ebb DH, Choy E, Raskin KA, Liebsch N, Hornicek FJ, Delaney TF. Proton-based radiotherapy for unresectable or incompletely resected osteosarcoma. Cancer. 2011 Oct 1;117(19):4522-30. doi: 10.1002/cncr.26037. Epub 2011 Mar 29. |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 48 months |
|
|
|
| 4 |
| 4 |
| 3 |
| 4 |
| 4 |
| 4 |
|
| Hospitalization | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment | Shortness of breath and bronchitis admitting for antibiotics |
|
| Hospitalization/Death | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Non-systematic Assessment | Respiratory distress from tumor compression of airways, bleeding during airway stenting procedure leading to death. |
|
|
| Anemia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment | Grade 2 or greater |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE v4.0 | Non-systematic Assessment | Grade 2 or greater |
|
| Pain | Psychiatric disorders | CTCAE v4.0 | Non-systematic Assessment | Grade 2 or greater |
|
Not provided
Not provided
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008670 |
| Metals |
| D055585 | Physical Phenomena |