Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas

Study ID
STU 042011-075

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Safee Ahmed
214-633-1751
safee.ahmed@utsouthwestern.edu

Principal Investigator
Robert Timmerman

Summary

This study is a single arm phase ii pilot trial. Patients enrolled on the trial will undergo implantation of high activity iodine-125 seeds into their pituitary adenoma as outlined in sections 6 and 7. The tumor response to treatment will be monitored as well as change in visual fields, associated adverse effects, progression free survival and patient reported outcomes.

Participant Eligibility


* Pathological or radiographic diagnosis of a pan-invasive pituitary macroadenoma

* Pan-invasive for the purposes of the protocol will be defined as meeting each of the following 2 major criteria: 1. tumor volume greater than 20 cc at enrollment, and 2. suprasellar extension. In addition, a pan-invasive tumor must meet any one of the following 3 minor criteria, a) unresectable tumor invasion into a cavernous sinus, b) bone or bone marrow invasion into the clivus or temporal bones, or c) tumor extension in any direction unlikely to be completely removed by specifically a transphenoidal surgical approach.

* Patients who meet the two major criteria above (1 and 2) and are medically inoperable for tumor resection (due to confounding co-existing medical problems) are eligible without meeting any of the three minor criteria (a, b, or c).

* Patients should be immediately threatened for vision loss or other significant neurological impairment directly related to tumor mass effect. As such, all patients enrolled would likely benefit from tumor response (shrinkage).

* Patients must have visible tumor on imaging studies (MRI or CT)

* The patient[Single Quote]s Zubrod performance status must be 0-3.

* Patients must be at least 18 years of age.

* MRI or CT scan of the brain including the entire skull base and all areas of tumor extension done 45 or fewer days prior to study entry