NCT01886105

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

Terminated Phase 2 Results posted Last updated 29 October 2019

What this trial tests

Phase 2 trial testing Sm-EDTMP in Metastatic Osteosarcoma in 4 participants. Terminated before completion.

Timeline

19 August 2013

Primary endpoint
11 December 2015

11 June 2017

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	19 August 2013
Primary completion	11 December 2015
Estimated completion	11 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Sm-EDTMP — full drug profile →
• Autologous Stem Cell Infusion — full drug profile →
• External Beam Radiotherapy

Conditions studied

• Metastatic Osteosarcoma — all drugs for Metastatic Osteosarcoma →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

Adults 10 to 65, any sex, with Metastatic Osteosarcoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Treated Participants With 6-month Progression Free Survival Primary · 6 months post-intervention

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

Group	Value	95% CI
SmEDTMP/Autologous Stem Cell Infusion/RT	0

Short and Long-term Side Effects of Combined Infusional Samarium-153 EDTMP and External Beam Radiotherapy as Assessed by Number of Participants With Toxicity Secondary · Up to 48 months

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.

Group	Value	95% CI
SmEDTMP/Autologous Stem Cell Infusion/RT	4

Adverse events — posted to ClinicalTrials.gov

Time frame: up to 4 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

SmEDTMP/Autologous Stem Cell Infusion/RT

Serious: 3/4 (75%)

Deaths: 4/4

Serious adverse events (3 terms)

Reaction	System	SmEDTMP/Autologous Stem Ce…
Hospitalization	Respiratory, thoracic and mediastinal disorders	—
Hospitalization	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Hospitalization/Death	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (4 terms — click to expand)

Reaction	System	SmEDTMP/Autologous Stem Ce…
Nausea	Gastrointestinal disorders	—
Anemia	Blood and lymphatic system disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Pain	Psychiatric disorders	—

Most-reported serious reactions: Hospitalization, Hospitalization, Hospitalization/Death.

Data from ClinicalTrials.gov NCT01886105 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bone Sarcomas in Pediatrics: Progress in Our Understanding of Tumor Biology and Implications for Therapy.
   Rivera-Valentin RK, Zhu L, Hughes DP. · · 2015 · cited 31× · PMID 26002157 · DOI 10.1007/s40272-015-0134-4
2. Radiotherapy in bone sarcoma: the quest for better treatment option.
   Locquet MA, Brahmi M, Blay JY, Dutour A. · · 2023 · cited 15× · PMID 37563551 · DOI 10.1186/s12885-023-11232-3