Clinical trial NCT01444209: Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas
Official title: Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pituitary Macroadenoma
Keywords: pituitary gland
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-09-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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's Zubrod performance status must be 0-3.
* Patients must be at least 18 years of age.
* Mandatory Imaging Studies: Must be done 45 or fewer days prior to :

MRI or CT scan of the brain including the entire skull base and all areas of tumor extension

Exclusion Criteria:

* Patients who are unable to undergo general anesthesia
* Patients who are unable to undergo placement of a stereotactic head frame
* Patients who are unable to provide informed consent
* Patients who are pregnant or nursing
* Patients with severe kidney dysfunction
* Patients who have contraindications to MRI, such as implanted pacemaker device
* Patients with diagnosis of pituitary carcinoma

Primary outcomes:
measure: Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.
timeFrame: 12 months
Secondary outcomes:
measure: Change of the Patient's Humphrey Visual Field Testing
timeFrame: 5 years
measure: Potential Toxicities Associated With Interstitial Seed Placement
timeFrame: 5 years
measure: Progression Free Survival
timeFrame: 5 years
measure: The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)
timeFrame: 5 years
measure: The Cost-utility of the Treatment Arm (in Terms of the Primary Outcome) in Comparison With Other Widely Accepted Cancer and Non-cancer Therapies
timeFrame: 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Robert Timmerman, MD
role: PRINCIPAL_INVESTIGATOR
References: