Phase 2 N=11 Treatment

Samarium Sm 153 and Stem Cell Transplant Followed By Radiation Therapy Patients With Osteosarcoma

Sarcoma

Bottom Line

View on ClinicalTrials.gov: NCT00245011 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2015

Primary outcome: Primary: Tumor Response — 10 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: filgrastim (Biological); ifosfamide (Drug); peripheral blood stem cell transplantation (Procedure); Sm-EDTMP (low dose) (Radiation); sm-EDTMP (higher dose) (Radiation)
Age: Pediatric, Adult · 13+ yrs
Sex: All
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Tumor Response	10	—
SECONDARY Predictive Value of Imaging Studies	—	—
SECONDARY Overall and Progression-free Survival After Study Treatment	NA; 79	—
SECONDARY Toxicity at End of Study Treatment	3; 1; 11; 11; 5	—
SECONDARY Long Term Side Effects of Infusional Samarium-153 After Study Treatment	—	—
SECONDARY Correlative Dose of Radiation by Low Dose and High Dose Samarium-153	—	—

Summary

RATIONALE: Radioactive drugs, such as samarium Sm 153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and samarium Sm 153 lexidronam pentasodium. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving samarium Sm 153 lexidronam pentasodium together with a peripheral stem cell transplant and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving samarium Sm 153 lexidronam pentasodium together with autologous stem cell transplant and radiation therapy works in treating patients with recurrent or refractory, metastatic, or unresectable osteosarcoma.

Eligibility Criteria

Inclusion

Diagnosis of osteosarcoma
High-risk disease, meeting 1 of the following criteria:
Recurrent disease
Refractory to conventional therapy
Newly diagnosed metastatic disease with ≥ 4 pulmonary nodules or multiple bone lesions
Unresectable primary tumor
Prior intralesional resection allowed
Measurable disease by technetium Tc 99m diphosphonate bone scan
Refractory to all standard therapies or highly unlikely to respond to conventional treatment
Performance status Karnofsky 60-100%
Life expectancy more than 8 weeks
Absolute neutrophil count > 500/mm^3
Platelet count > 50,000/mm^3
Creatinine clearance > 70 mL/min OR * Radioisotope glomerular filtration rate normal
Recovered from prior chemotherapy

Exclusion

Pregnant or nursing
Positive pregnancy test for females of childbearing potential
Fertile patients do not agree to use effective contraception
Prior radiotherapy to the site of currently active disease
Concurrent enrollment on protocol JHOC-J0094 allowed

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00245011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.