Radioactive Iodine Implants for Pan-invasive Pituitary Macroadenomas

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01444209
First received: September 22, 2011
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pituitary Macroadenoma
Radiation: Iodine Implants
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interstitial Radioactive Iodine Implants for the Treatment of Pan-invasive Pituitary Macroadenomas

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Partial response (reduction in 30% of tumor volume) or greater response within 12 months from the implant procedure. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of the patient's Humphrey visual field testing [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Potential toxicities associated with interstitial seed placement [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Progression free survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • The effect of the treatment on quality of life evaluations (patient reported outcomes) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • The cost-utility of the treatment arm (in terms of the primary outcome) in comparison with other widely accepted cancer and non-cancer therapies [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiation Therapy
Interstitial Radioactive Iodine Implants
Radiation: Iodine Implants
Interstitial Radioactive Iodine Implants

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444209

Contacts
Contact: Robert Timmerman, MD 214-645-8525
Contact: Jean Wu, MSN 214-645-8525

Locations
United States, Texas
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Robert Timmerman, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Robert Timmerman, MD University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01444209     History of Changes
Other Study ID Numbers: STU 042011-075
Study First Received: September 22, 2011
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
pituitary gland

Additional relevant MeSH terms:
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014