Study of the Efficacy of Direct Intratumoral Injection of Absolute Ethanol in Treating Symptomatic Spinal Tumors

Date de début de l'étude : 1 juin 1994

Patients must have a vertebral tumor documented by MRI. Vertebral height must be at least 50 percent of adjacent vertebrae. Patients must be symptomatic from their spinal tumor. Treatment attempts to reduce the size of, or eliminate, their tumors and to relieve their symptoms. The treatment of the vertebral tumor must be indicated based on the patient's condition. Prior surgical or radiation therapy for the vertebral tumor will not result in exclusion from the study if there is radiographic evidence of tumor and there is evidence of persistent local pain, epidural compression, or neurological deterioration related to the vertebral tumor. The patient must be able to comprehend the risks of the therapy and must be able to give informed consent. Pregnancy will exclude participation due to the radiation exposure involved in this protocol. Bleeding disorders will exclude a patient from the protocol unless the disorder can be corrected prior to treatment. Patients must have no contraindications to MRI scanning. Patients undergoing ethanol injection in the x-ray department must be able to lay prone for at least one hour with intravenous sedation and analgesia. Patients whose tumors have not responded to radiation therapy will be candidates for ethanol infusion. Patients with tumors in areas that have received maximal radiation doses to the spinal cord will be candidates for ethanol infusion. Patients whose poor general condition precludes open surgery will be candidates for ethanol infusion. Patients who wish to avoid the morbidity and potential mortality of open surgery will be candidates for ethanol injection. Patients with radioresistant tumors such as melanoma or prostate carcinoma are candidates for ethanol infusion even if they have not undergone prior irradiation. Patients with radiation-sensitive spinal tumors such as breast, kidney, and lung carcinoma, lymphoma, myeloma, Ewing's sarcoma, neuroblastoma, seminoma will not be entered into the protocol unless their tumors have either responded to radiation or lie at spinal cord levels that have already received maximal tolerable radiation doses. Patients with less than a 2 month life expectancy will be excluded. Patients with symptomatic vertebral metastases at more than 3 spinal levels will be excluded. Patients with asymptomatic vertebral metastases will be excluded.