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High Dose Samarium-153 With Peripheral Blood Stem Cell Support in High Risk Osteogenic Sarcoma


Phase 2
13 Years
50 Years
Not Enrolling
Both
Sarcoma

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Trial Information

High Dose Samarium-153 With Peripheral Blood Stem Cell Support in High Risk Osteogenic Sarcoma


OBJECTIVES:

Primary

- Determine the clinical response in patients with recurrent or refractory, metastatic,
or unresectable osteosarcoma treated with high-dose samarium Sm 153 lexidronam
pentasodium (^153Sm-EDTMP) and autologous peripheral blood stem cell transplantation
followed by external-beam radiotherapy.

- Correlate the amount of radiation delivered to a tumor with low-dose ^153Sm-EDTMP with
that of high-dose ^153Sm-EDTMP in patients treated with this regimen.

Secondary

- Determine the overall and progression-free survival of patients treated with this
regimen.

- Determine the toxicity of this regimen in these patients.

- Determine the long-term effects of this regimen in these patients.

- Determine the predictive value of fludeoxyglucose F 18 positron emission tomography
(FDG-PET), diffusion-weighted MRI, and magnetic resonance spectroscopy for evaluation
of treatment response in patients treated with this regimen.

OUTLINE: Patients are stratified according to resectability of the primary tumor (recurrent,
refractory, or very high-risk disease vs unresectable primary tumor).

- Mobilization and collection of autologous peripheral blood stem cells (PBSCs)* :
Patients receive ifosfamide IV daily for 5 days followed by filgrastim (G-CSF)
subcutaneously daily. Patients then undergo leukapheresis for collection of autologous
PBSCs until ≥ 2 x 10^6 CD34-positive cells/kg are collected.

NOTE: *Patients who have undergone PBSC collection before study entry proceed to high-dose
samarium Sm 153 lexidronam pentasodium (153Sm-EDTMP) infusion without mobilization and
collection of autologous PBSCs.

- 153Sm-EDTMP infusion: Patients receive a trace dose of ^153Sm-EDTMP** IV over 1-2
minutes and undergo bone scan 4, 24, and 48-72 hours later. Six weeks later, patients
receive high-dose ^153Sm-EDTMP IV over 1-2 minutes and undergo repeat bone scans 4, 24,
and 48-72 hours later.

NOTE: **Patients may receive the trace dose on protocol JHOC-J0094.

- Autologous peripheral blood stem cell transplantation (PBSCT): Between 12-14 days after
administration of high-dose ^153Sm-EDTMP, patients undergo autologous PBSCT. Beginning
2 days later, patients receive G-CSF IV daily.

- External-beam radiotherapy: Patients then undergo external-beam radiotherapy to the
sites of bulky disease.

- Surgery: Some patients may also undergo surgical resection of residual disease. After
completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Performance status

- Karnofsky 60-100%

Life expectancy

- More than 8 weeks

Hematopoietic

- Absolute neutrophil count > 500/mm^3

- Platelet count > 50,000/mm^3

Hepatic

- Not specified

Renal

- Creatinine clearance > 70 mL/min OR

- Radioisotope glomerular filtration rate normal

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy

- Recovered from prior chemotherapy

Radiotherapy

- No prior radiotherapy to the site of currently active disease

Surgery

- See Disease Characteristics

Other

- Concurrent enrollment on protocol JHOC-J0094 allowed

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response

Outcome Time Frame:

1 week after study treatment

Safety Issue:

No

Principal Investigator

David M. Loeb, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

J0347 CDR0000447134

NCT ID:

NCT00245011

Start Date:

October 2004

Completion Date:

March 2009

Related Keywords:

  • Sarcoma
  • recurrent osteosarcoma
  • metastatic osteosarcoma
  • localized osteosarcoma
  • Osteosarcoma
  • Sarcoma

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410