Clinical Trial Guidelines
The new Diatide clinical trial aims to give more information about how well tin-117m DTPA works against bone cancer pain, and to compare it directly with Metastron.
In order to participate in the study, patients must have no substantial damage to their bone marrow as a result of their cancer, as well as no bone fractures. They cannot have had radiation therapy for three months, and cannot have taken Metastron or other radiopharmaceuticals in the three months before receiving the tin. Also, they may not have surgery planned.
Prospective patients are screened via a bone scan that shows physicians the location of their tumors, and a questionnaire asking them to indicate the areas of their body where they feel pain. The two are compared to make sure they correlate.
Patients in the trial receive a one-time intravenous dose of either the tin compound or Metastron, and keep a daily diary of the effect on their pain for 12 weeks afterward. They also track their use of narcotic and non-narcotic pain killers and are examined several times by a physician. Both pain relief and any toxicity to bone marrow are being gauged.
Patients receiving tin-117m DTPA during the trial are being given one of three doses, either one of the two amounts used in the previous BNL studies or a higher dose. Patients receiving Metastron receive the approved therapeutic dose.