Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

NCT01444209 | Terminated Phase 2 Results DMC

• 1 other identifier: STU 042011-075
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Macroadenoma

Keywords

pituitary gland

Outcome Measures

Primary Outcomes (1)

• Partial Response (Reduction in 30% of Tumor Volume) or Greater Response Within 12 Months From the Implant Procedure.

  12 months

Secondary Outcomes (5)

• Change of the Patient's Humphrey Visual Field Testing

  5 years

• Potential Toxicities Associated With Interstitial Seed Placement

  5 years

• Progression Free Survival

  5 years

• The Effect of the Treatment on Quality of Life Evaluations (Patient Reported Outcomes)

  5 years

• The Cost-utility of the Treatment Arm (in Terms of the Primary Outcome) in Comparison With Other Widely Accepted Cancer and Non-cancer Therapies

  5 years

Study Arms (1)

Radiation Therapy

EXPERIMENTAL

Interstitial Radioactive Iodine Implants

Radiation: Iodine Implants

Interventions

Iodine Implants RADIATION

Interstitial Radioactive Iodine Implants

Radiation Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Pituitary Diseases

Condition Hierarchy (Ancestors)

Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Limitations and Caveats

Early termination due to failure to accrue

Results Point of Contact

• Title: Dr. Robert Timmerman
• Organization: University of Texas Southwestern Medical Center

robert.timmerman@utsouthwestern.edu

214/645-7637

Study Officials

• Robert Timmerman, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 30, 2011
• Study Start: September 30, 2011
• Primary Completion: October 20, 2020
• Study Completion: January 20, 2021
• Last Updated: November 30, 2021
• Results First Posted: November 30, 2021

Record last verified: 2021-11

Locations

US (1)