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Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pituitary Adenomas, Prolactinomas, Cushing's Disease

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Trial Information

Targeted Therapy With Lapatinib in Patients With Recurrent Pituitary Tumors Resistant to Standard Therapy


Inclusion Criteria:



- Patients with nonfunctioning adenomas who have undergone at least one prior surgical
resection and have demonstrated recurrence on MRI

- Patients with prolactinomas who are resistant to dopamine agonist therapy

- Patients with recurrent Cushing's disease

- Patients with visual field deficits and/or compression of the optic chiasm must be
stable for at least 6 months

Exclusion Criteria:

- Patients with compromised visual fields and/or compression of the optic chiasm on MRI
that has not been stable for last 6 months.

- Patients that have reduced left ventricular ejection fraction less than 50%

- Patients with moderate to severe hepatic impairment

- Patients that are pregnant or lactating

- Patients under the age of 18

- Active hepatitis

- Known previous HIV Positive

- Concurrent cancers

- Life expectancy less than one year

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary outcome in nonfunctioning adenomas: stabilization of tumor volume and mean tumor diameter on MRI. Stabilization is defined as < 2 mm change in any dimension. MRIs will be performed at baseline and at 3 and 6 months.

Outcome Time Frame:

baseline and every 3 months

Safety Issue:

No

Principal Investigator

Shlomo Melmed, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cedars-Sinai Medical Center

Authority:

United States: Institutional Review Board

Study ID:

18129

NCT ID:

NCT00939523

Start Date:

July 2009

Completion Date:

July 2014

Related Keywords:

  • Pituitary Adenomas
  • Prolactinomas
  • Cushing's Disease
  • recurrent nonfunctioning adenoma
  • prolactinomas
  • Cushing's disease
  • resistant pituitary tumors
  • aggressive pituitary tumors
  • Adenoma
  • Cushing Syndrome
  • Pituitary ACTH Hypersecretion
  • Pituitary Neoplasms
  • Prolactinoma

Name

Location
Pituitary Center Cedars-Sinai Medical Center Los Angeles, California  90048