External Beam Radiation Therapy and 153Sm-EDTMP in Treating Patients with High-Risk Bone Cancer or Solid Tumors Metastatic to the Bone

Status: administratively complete

This clinical trial studies external beam radiation therapy and samarium Sm-153 lexidronam pentasodium (153Sm-EDTMP) in treating patients with bone cancer that is likely to recur (come back), or spread (high-risk) or solid tumors that have spread from the primary site (place where they started) to the bone (metastatic). Radiation therapy uses high energy x rays to kill tumor cells. Radioactive drugs, such as samarium Sm-153 lexidronam pentasodium, may carry radiation directly to tumor cells and not harm normal cells. Giving external beam radiation therapy and samarium Sm-153 lexidronam pentasodium may kill more tumor cells.

Inclusion Criteria

Patient must have unresectable primary tumor or metastases (including tumors with an intralesional resection) * For Stratum 1, patients must have a confirmed histologic diagnosis of osteosarcoma * For Stratum 2, any histologically confirmed solid tumor diagnosis is eligible
Patients must have measurable disease that is avid for phosphonate compounds as demonstrated by a positive technetium TC-99m (Tc-99m) bone scan; not all lesions must be positive on bone scan
Measured creatinine clearance > 70 ml/min/1.73 m^2 or normal radioisotope glomerular filtration rate (GFR)
Platelet count > 50,000/mm^3
Absolute neutrophil count > 500/mm^3
Life expectancy of > 8 weeks
Karnofsky performance status > 50%
Patients must have recovered from the effects of any prior chemotherapy, as determined by the treating physician and study team, based in part on organ function defined above
A stem cell product collected prior to the infusion of 153Sm-EDTMP must be available, either by peripheral stem cell mobilization or bone marrow harvest prior to trial entry; a minimum of 2 x 10^6 cluster of differentiation (CD)34+ cells/kg ideal body weight is required
The patient and/or the patient’s legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services

Exclusion Criteria

Patients must not be pregnant or breastfeeding; sexually active patients are strongly advised to use accepted, effective forms of contraception
Patients who have received prior radiotherapy to all areas of current active disease are ineligible

PRIMARY OBJECTIVES:

I. To assess the clinical response of high-risk osteogenic sarcoma to high-dose 153Sm-ethylenediamine tetramethylene phosphonic (EDTMP) and external beam radiotherapy. (Stratum 1)

II. To estimate the response rate of diseases other than osteosarcoma to the combination of high-dose 153Sm-EDTMP and external beam radiotherapy. (Stratum 2)

SECONDARY OBJECTIVES:

I. To describe the toxicity and long-term effects of combined infusional 153Sm-EDTMP and external beam radiation therapy.

II. To image tumors using (18F) fluoromisonidazole (18F-MISO) positron emission tomography (PET) scanning before and after treatment, and compare with clinical response as measured by radiographic imaging and/or histology.

III. To describe the distribution of absorbed doses delivered to each targeted lesion and the distribution of lesion equivalent uniform dose delivered to each patient.

IV. To determine dosimetry measurements after initial tracer dosing, predict target total radiation exposure to tumor based on linear kinetics previously described, and calculate a subsequent combined treatment dose.

V. To observe overall survival and time to progression in patients treated with combined infusional 153Sm-EDTMP and external beam radiation therapy, and model any relationship between total absorbed dose and progression. (Stratum 1)

OUTLINE:

Patients receive samarium Sm-153 lexidronam pentasodium intravenously (IV) over 1-2 minutes on day 8 and undergo external beam radiation therapy (EBRT) between days 15-22. Patients then undergo infusion of previously collected autologous peripheral blood stem cells or bone marrow on day 24.

After completion of study treatment, patients are followed up at 4, 6, 8, 12, 18, 24, 30, 36, 42, 48, and 60 months.

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External Beam Radiation Therapy and 153Sm-EDTMP in Treating Patients with High-Risk Bone Cancer or Solid Tumors Metastatic to the Bone

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