The purpose of this study is to learn the dose of the investigational drug 153Sm-EDTMP that can be given to patients with cancer or those whom have not responded to therapy with surgery and chemotherapy. The study will also evaluate the side effects of this drug. 153Sm-EDTMP was eliminated relatively quickly after each infusion with uptake remaining in metastases or skeleton only by 24 hr. Bladder toxicity has not occurred. We are currently using IV hydration as the only means of cystitis prevention. Total body radiation levels on day 13 have been consistently very low, well below 1 mRem/hr at 1 meter safety limit. All patients have had stem cells infused 14 days after high dose 153Sm-EDTMP. Stem cell infusions have been given as outpatient observation with side effects limited to those usually associated with DMSO cryopreservative (temporary nausea, anorexia for 4-6 hrs). All patients have become temporarily pancytopenic after 153Sm-EDTMP. Once ANC is less than 500, patients have been provided with G-CSF to speed neutrophil recovery. Platelet transfusion requirements have been variable. Most patients have required only 1-3 platelet transfusions for platelet counts <20,000. Some but not all patients have also been transfused with packet red blood cells. Recovery of neutrophil count has generally occurred before day 14. No serious infections have been documented. Only 1 patient out of 8 has had a hospital admission associated with fever and antibiotic administration during neutropenia. The fever was probably catheter related and resolved with catheter removal. Since all patients have recovered from hematopoietic toxicity within 30 days, stem cell support successfully ameliorated hematopoietic toxicity in all patients treated with high dose 153Sm-EDTMP. Furthermore, since no serious non-hematologic toxicities have been seen, stem cell infusion offers promise of a means to escalate doses of 153Sm-EDTMP to even higher levels.
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