A Dose Finding Study of CycloSam? (153Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewings Sarcoma, and other solid tumor(s) to the bone all eligible).

Inclusion Criteria

1. Subjects will be between the ages of 15 and 75, inclusive.

2. Subjects must have a histologically confirmed diagnosis of a solid tumor metastatic to

bone, or a histologically confirmed diagnosis of a solid tumor to the bone or

metastatic to the bone.

3. Subjects must have measurable disease on anatomic imaging that is also avid for

phosphonate compounds as demonstrated by a positive 99mTc diphosphonate bone scan. Not

all lesions must be positive on bone scan.

4. Adequate organ function, including:

i. Adequate renal function, defined as a measured creatinine clearance >70 mL/min/1.73

m2 or normal radioisotope glomerular filtration rate (GFR).

ii. Adequate hematologic function, defined as a platelet count >100,000 cells/mm3 and

an absolute neutrophil count (ANC) >1,000 cells/mm3.

5. Life expectancy of at least eight weeks.

6. Karnofsky performance status >50%.

7. Subjects must have adequately 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. Toxicities from previous therapies must have recovered to CTCAE v5.0

grade ≤1. Subjects with Grade 2 anemia per CTCAE v5.0 will be permitted as long as the

subject has normal cardiac function.

8. Adequate cardiac function. Subjects with previously identified cardiac disease will be

eligible, as 153Sm-DOTMP is not expected to cause cardiac dysfunction and is only

expected to result in very transient hypocalcemia.

9. A stem cell product collected either by peripheral stem cell mobilization or bone

marrow harvest prior to the infusion of CycloSam® must be available, prior to trial

entry. A minimum of 2 x 106 CD34+ cells/kg ideal body weight are required.

10. Female subjects of child-bearing potential (defined as premenopausal and capable of

becoming pregnant) must have a negative serum pregnancy test at the Screening visit.

Females must be surgically sterile, postmenopausal for at least one year prior to

Screening (no other medical cause involved) with a Follicle Stimulating Hormone (FSH)

level of greater than 40 mIU/mL or must be using a highly effective method of birth

control and agree to its use for at least 30 days following the last dose of

153Sm-DOTMP. Highly effective methods of contraceptive are defined as tubal ligation

or an approved hormonal contraceptive such as oral contraceptives, patches, implants,

injections, rings, or hormonally-impregnated intrauterine device.

11. Male subjects with partners of child-bearing potential must agree to use highly

effective methods of contraception for at least 90 days after the last dose of

153Sm-DOTMP.

12. The subject and/or the subject's legally authorized guardian, if the subject is a

minor, must acknowledge in writing that informed 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.

13. Subjects must have previously received effective treatment for their underlying

disease and have no potentially curative options available.

14. The concurrent use of hormonal therapies or bisphosphonates is acceptable, provided

the latter do not render target lesions invisible on 99mTc bone scan. Subjects will

have the option to re-screen up to once more after seven days if they do not initially

meet all of the inclusion criteria

Exclusion Criteria

1. Subject is pregnant or breastfeeding.

2. Subject is sexually active and does not agree to use accepted, effective forms of

contraceptive.

3. Subject has received prior radiotherapy to all known areas of current active disease.

4. Subject has a body mass index (BMI) > 50 kg/m2.