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Autonomic Phenotype Before and After Akt Inhibition

This study is currently recruiting participants.
Verified January 2013 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Satish R. Raj, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01593579
First received: May 4, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

Some Akt inhibitors have produced functional cardiovascular effects such as marked hypotension that may limit their clinical benefit. There are no current data on whether this autonomic failure presents in humans at clinically used doses. We will test the hypothesis that Akt inhibition causes an acute decrease in sympathetic tone and lowers blood pressure.


Condition Intervention
Diagnosis of Melanoma
 Behavioral: Autonomic Function Tests
Other: supine and standing catecholamines

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Autonomic Phenotype Before and After Akt Inhibition: Akt Therapy for Melanoma Sub-study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Drop in systolic blood pressure before and after Akt treatment [ Time Frame: 8 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients with Melanoma
Patients with Melanoma that are enrolled in a clinical trial at the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
 Behavioral: Autonomic Function Tests
Patients will undergo Autonomic Function testing (AFT) before and 8 hours after Akt Inhibition therapy. AFT includes: Supine & standing heart rate & blood pressure, 10 minute head up tilt, cardiac output, sinus arrhythmia, hyperventilation, sustained handgrip, valsalva manuever, and cold pressor test.
Other: supine and standing catecholamines
patients will have blood drawn from supine and standing catecholamines.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients will have a diagnosis of Melanoma and be participating in a clinical trial with an arm using oral Akt therapy. Patients will be recruited from the Vanderbilt Ingram Cancer Center.

Criteria

Inclusion Criteria:

  • Diagnosed with melanoma with a BRAF mutation and relapse following therapy with a BRAF inhibitor
  • Enrolled in a clinical trial through the Vanderbilt Ingram Cancer Center (VICC) including an arm with an oral Akt inhibitor
  • Able and willing to provide informed consent

Exclusion Criteria:

  • Factors which in the investigator's opinion would prevent the participant from completing the protocol, including poor compliance during previous studies or an unpredictable schedule
  • Unable to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593579

Contacts
Contact: Satish Raj, MD, MSCI 615-322-2931 adcresearch@vanderbilt.edu
Contact: Jeffrey Sosman, MD 615-343-6653 jeff.sosman@Vanderbilt.Edu

Locations
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Satish Raj, MD, MSCI            
Sub-Investigator: Jeffrey Sosman, MD            
Sub-Investigator: Igor Puzanov, MD, MSCI            
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Satish R. Raj, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01593579     History of Changes
Other Study ID Numbers: 120390, VR3689
Study First Received: May 4, 2012
Last Updated: January 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
melanoma
autonomic failure
hypotension
akt therapy

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 18, 2013