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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).

The primary objective of this study is:
To determine the MTD of CycloSam®, given as a tandemly administered pair of doses to subjects with one or more solid tumor(s) in the bone or metastatic solid tumors to the bone that are visible on bone scan.

The secondary objectives of this study are:
1. To describe the toxicity and long-term effects of infusional CycloSam®;

2. To assess the clinical response of solid tumors to the bone or metastatic to the bone to therapy with infusional CylcoSam®;

3. To describe the distribution of absorbed doses delivered to each targeted lesion and the distribution of lesion equivalent uniform dose delivered to each subject;

4. To observe overall survival and time to progression in subjects treated with infusional
CycloSam®, and model any relationship between total absorbed dose and progression;

5. To assess the extent of pain palliation using a visual analogue scale (VAS) in subjects
treated with infusional CycloSam®.

Protocol Number: 052201
Phase: Phase I
Applicable Disease Sites: Any Site
Breast
Lung
Prostate
Drugs Involved: CycloSam (153Sm-DOTMP)
Principal Investigator: Sanjay Goel
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.