Pituitary Network Association - Clinical Trials

A clinical trial is an organized study conducted in order to answer specific questions about a new treatment or a new way of using a known treatment. Each study tries to increase medical knowledge and to find new and better ways to help patients. Besides studying new drugs, clinical trials study new combinations of drugs already used, new ways of giving treatment, and how changes in lifestyle can help patients. Other clinical trials compare the best known standard therapy with a newer therapy to see if one produces more cures and causes fewer side effects than the other.

Most clinical trials are carried out in steps called phases. Each phase is designed to find different information. Patients may be eligible for studies in different phases, depending on their general condition, the type and stage of their disorder, and what therapy, if any, they have already had. Patients are seen regularly to determine the effect of the treatment, and treatment is always stopped if side effects become too severe.

With information about ongoing and upcoming clinical trials around the world and all the latest news on medical advances, this section promises to be yet another important source of information for pituitary patients.

Disclaimer: This page contains information about clinical trials and is not intended to replace the advice of a health care professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient and advise you of the associated risks.

Novartis sponsored study: CSOM230B2305
Cushing’s Disease Study

The purpose of this clinical research study is to determine the most safe and effective dose of an investigational drug for participants 18 years of age and older who have ACTH-dependent Cushing’s disease. An “investigational drug” is a drug that is being tested and is not approved for sale in the United States by the U.S. Food and Drug Administration (FDA).
http://www.novartisclinicaltrials.com/webapp/etrials/DiseaseID64/
Cushing's-Disease-clinical-trials.go?pl_id=bmrpitu

NIH sponsored study: 5R01NS051439
Molecular Targeting and Imaging of Pituitary Adenomas

The aim of the study is to develop new therapy and imaging for pituitary tumors based on a key discovery from analysis of human pituitary adenomas. We have discovered a new molecular marker – the folate receptor (1). This marker allows us to image pituitary tumors in vivo using the vitamin folic acid coupled to technetium-99 and SPECT imaging so that we can identify patients that have folate receptors on their tumors (2). This allows selection of tumors that may be treatable by targeted therapy in the very near future. We are already testing candidate compounds that show promise in vitro and in vivo. Similar discoveries and applications of receptor biology led to new drugs for the treatment of prolactin-secreting tumors (bromocriptine, carbegoline) and growth-hormone secreting tumors (somatostatin, pegvisomant) with less need for surgery. The project is funded by a $1.6 million grant from the National Institutes of Health (NIH).You can find out more on the NIH website:
http://crisp.cit.nih.gov/crisp/CRISP_LIB.getdoc?textkey=7218090&p_grant_num=5R01NS051439-03&p_query=&ticket=33479654&p_audit_session_id=20701615
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Patients with recently diagnosed pituitary tumors over 18years and are not pregnant are eligible, please call or for more information on this research study.

Nelson M Oyesiku, MD, PhD, FACS (Principal Investigator)
Professor & Vice-Chairman, Neurosurgery
Emory University School of Medicine
Dept. of Neurosurgery
1365-B Clifton Rd, NE Atlanta, GA 30322
Phone: 404-778-5770
Fax: 404-778-4472
Admin Asst: 404-778-5969
Email: noyesik@emory.edu
Web: http://neurosurgery.emory.edu/Faculty%20Oyesiku.htm

REFERENCES
1. Evans, C-O, Reddy, P, Brat D.J., O’Neill E.B., Branch B., Stevens, V.L., Oyesiku, N.M. Differential Expression of Folate Receptor in Pituitary Adenomas, Cancer Research 63:4218-4224, 2003
2. Oyesiku, N.M., Halkar R. K., Galt J. R., Faraj B. A., Evans C.O. SPECT/CT of FolateScan ( Tc-99m EC20) in pituitary tumors: A novel imaging tracer and Technique. Journal of Nuclear Medicine Vol 45 (5 S) 368P 2004

Diabetic Neuropathy: A clinical research study looking for patients who have been diagnosed with Type 1 or 2 Diabetes, experiencing painful neuropathy for 6 months to 10 years.

This study will include volunteers diagnosed with diabetes (type 1 or type 2) who have painful neuropathy. The study will evaluate the safety and effectiveness of three different doses of an investigational drug, compared to a non-medicinal placebo. To participate, you must be at least age 18, diagnosed with type 1 or type 2 diabetes, and have had painful diabetic peripheral neuropathy confirmed by neurological exam for six months up to 10 years prior to screening. Additional criteria may apply. If eligible, you will receive investigational drug and study-related medical care at no cost. Compensation for time and travel also is available.
The research site is in Little Rock, Ark.
More information
Please see http://www.centerwatch.com/patient/studies/cat253.html

Research Study- Rosiglitazone Treatment of Cushing’s Disease that have failed standard therapies/prior to Pituitary Surgery

Purpose: No currently available medical treatment, both reduces the excess hormones produced by Cushing’s disease and tumor size. We wish to examine the effects (good or bad) of rosiglitazone, a drug treatment currently approved to treat diabetes on pituitary tumor growth and hormone secretion. There are two separate studies. In the first, called study 1, patients with newly diagnosed Cushings syndrome due to a pituitary tumor will be seen by the doctor for a first visit and then once a week for six weeks while taking rosiglitazone when they are awaiting pituitary surgery. You will be asked to complete a simple questionnaire regarding symptoms and undergo a basic physical examination at each visit. You will be given a supply of the study drug and a blood sample will be drawn at your first visit and every 2 weeks (approximately 6 times) and you will be asked to collect 24 hour urine collections for cortisol every week of the study (6 weeks), to test effects of rosiglitazone on your cortisol levels. The second study is similar in some respects but in study 2 we wish to examine the effects of rosiglitazone in patients with Cushings syndrome who have undergone at least one pituitary surgery. In study 2, our physicians will see you for a first visit and then every month for a total of 6 months while taking rosiglitazone and you will be asked to complete a simple questionnaire regarding symptoms and undergo a basic physical examination at each visit. You will be given a supply of the study drug, a blood sample will be drawn at your first visit and every 4 weeks (approximately 6 times), and you will be asked to collect 24 hour urine collections for cortisol every month (6 months). We will also be carrying out some tests of your pituitary function. A pituitary MR scan will be carried out at the start and at the completion of the study to determine if the pituitary tumor has gotten smaller on the drug treatment.
Criteria for subjects:

• Male or females; female patients must be either postmenopausal, and not receiving hormone replacement therapy or of childbearing potential, and practicing a medically acceptable method of birth control.
• Age: 18-65 years
• Clinically demonstrable ACTH-secreting tumor, evidence of biochemically active disease, this includes elevated 24 hour urinary free cortisol levels on at least 2 separate 24 hour urine collections a week apart.
• Lack of suppression of 0800h serum cortisol to <1.8 µg /dl following administration of dexamethasone 1 mg at 11 pm the night before and measurable plasma ACTH levels.
• Must have a pituitary tumor demonstrated on MRI performed with and without contrast
• Hypercortisolemic, and does not wish to receive alternate steroid lowering therapy such as ketoconazole and/or metryrapone.
• Must be minimum of 1 month after any recent pituitary surgery (study 2 only)

Number of patients: 15
Location: UCLA Medical Center
Principal Investigator: Anthony Heaney, MD
UCLA Medical Center- Investigator: Anthony Heaney, MD
UCLA-Harbor Medical Center- Investigator: Christina Wang, MD
Enrollment Period: 2006-2009

For more information or subject referrals contact:
Shameka Faulkner, Study Coordinator
Telephone (310) 825-5874
Email: sfaulkner@mednet.ucla.edu.
Fax: (310) 794-7654
UCLA Medical Center

Mailing Address:
900 Veteran Ave
Room 24-130
Los Angeles, CA 90095

Pregnant Women with Pituitary Problems and Prolactin Deficiency

The Reproductive Endocrine Unit at the Massachusetts General Hospital seeks healthy women with previous pituitary surgery, radiation, or Sheehan’s syndrome and prolactin deficiency, who wish to breastfeed, aged 18-45yrs. Volunteers may not be taking oral contraceptives or have had previous breast surgery. This study involves three 8 to 11hr admissions, 4 outpatient visits, administration of prolactin and blood draws. Up to $120 stipend.
Call Patty at 617-726-5387.
IRB Protocol # 2003-P-001209

Effects of Growth Hormone Administration on Cardiovascular Risk Markers in Men and Women with Cured Acromegaly

This 12-month research study will evaluate the relationship between growth hormone (GH) levels and heart disease in subjects cured of acromegaly. GH is a hormone that the pituitary gland normally produces, and GH deficiency is associated with an increased risk for heart disease. This study investigates whether physiologic GH replacement therapy will reduce cardiovascular risk in men and women ages 18 to 75 with GH deficiency following cure of acromegaly. Eligible subjects may undergo 8 to 10 outpatient hospital visits which will include measurements of metabolism, body fat and muscle, as well blood tests reflecting the health of blood vessels. Subjects will be remunerated up to $300 for their participation.

We will also enroll subjects who have active acromegaly, or who are cured from acromegaly with a GH deficiency, but have a contraindication to receiving GH for a cross-sectional study involving body composition and cardiovascular risk marker measurements.

For more information, please contact Lindsay Gunnell at (617) 724-1579 or lgunnell@partners.org or visit the MGH Neuroendocrine Clinical Center / Pituitary Tumor Center website at: http://pituitary.mgh.harvard.edu/

Growth Hormone and Testosterone Therapy for Panhypopituitary Women

Women who have lost all pituitary function age 18-55 will qualify. Growth Hormone (GH) will be given free of change for 24 months and testosterone in a female dose for 6 months. The growth hormone portion of the study is not placebo, but the testosterone part is. Patients will begin an appropriate dose of growth hormone regulated by an experienced pituitary physician. Part of the study is conducted at UCLA in Los Angeles, patients travel there twice. All expenses will be paid to the patients including a stipend for participating. Dr. David Cook is the principal investigator at OHSU. Interested patients call Stacy at 503-494-5317. For more information about the OHSU Pituitary Unit, please visit www.OHSUpituitary.com.

SOM230 Therapy for Patients with Cushing’s Disease

Patients with active Cushing’s disease (Cushing’s syndrome caused by an ACTH producing pituitary tumor) who have urine free cortisols more than 2x the upper limit of normal and are age 18 or greater will be eligible to be screened for this study. Qualifying patients will receive SOM230 (a new drug that effects all five somatostatin receptors) for a 16-day period to see if it effectively treats Cushing’s disease. Urine free cortisols (as well as other tests) will be assessed before and after drug treatment. All expenses will be paid to the patients including a stipend for participating. Dr. William Ludlam is the principal investigator at OHSU. Interested patients should call Chris at 503.494.6576
For more information about the OHSU Pituitary Unit, please visit www.OHSUpituitary.com.

Sandostatin LAR and Somavert: A Comparative Study

The OHSU Pituitary Unit is embarking on a study, which randomizes patients (50/50) with active Acromgaly to either Sandostatin LAR or Somavert drug therapy. There is no placebo arm to the study. Patients have to be 2 months or longer after surgery (no surgery is also acceptable) and have no history of prior drug therapy and/or irradiation. If pituitary tumor is remaining it must be 3 mm or further from the optic chiasm. Therapy, MRI's and blood tests will all be done at Oregon Health and Science University at no charge to volunteers. All travel expenses will be paid in addition.

If you qualify and are interested, contact Stacy at 503-494-5317.

Effect of Testosterone and Growth Hormone on Bone Structure

Both testosterone and growth hormone individually improve bone density in men who have deficiencies of these hormones. The purpose of this research study is to determine if the combination of testosterone and growth hormone improves bone structure more than testosterone alone. This study is for men who have documented pituitary disease, are deficient in testosterone and growth hormone, and have not taken growth hormone or testosterone within the past two years. Thirteen outpatient visits over a 2-year period are required. Bone structure will be evaluated three times (at the beginning, after 12 months, and after 24 months). Three kinds of tests will be performed: DEXA, MRI and p-QCT. All three are non-invasive tests of bone quality and low risk.

By participating in this study you will learn more about the health of your bones and other aspects of your health. Reports will be provided to you and to any physician you wish. The study covers the cost of all study procedures and medications.

Contact:
Helen Peachey RN, Research Coordinator

University of Pennsylvania Medical Center. Dept. of Endocrinology
First Floor Maloney Building, 36th and Spruce Streets
Philadelphia, PA 19104

Phone: 215-898-5664
E-mail: peacheyh@mail.med.upenn.edu

Click here for Research Subject Informed Consent Form

Study to Evaluate Testosterone-Gel in Prepubertal Boys (13-17 years old)

Some boys do not develop the changes of puberty when other boys their same age are starting puberty. This could be due to problems with chemicals in their body called hormones. Some of the hormones made in the pituitary gland (a part of the brain) helps a boy's body to make testosterone. Testosterone is a male hormone that helps the body change from a boy to a man.

A child could be born with a problem with the pituitary gland or had damage to the pituitary because of a brain tumor, radiation for other type of tumors or head trauma.

If your child is a boy 13 to 17 years of age and he has not started puberty, he may qualify to participate in a study using testosterone gel to replace the low levels of male hormones.

Testosterone-gel approved for used in adult men that do not make enough male hormone but have not been tested in boys.

Please contact the Study Doctors at Harbor-UCLA Medical Center to see if your child qualifies for this Research Study.

Catherine S. Mao, M.D.
Office: (310) 222-5295
e-mail: Mao@gcrc.rei.edu

Xiaodan Qu, M.D.
e-mail: xqu@gcrc.rei.edu

Clinical Trials and Noteworthy Treatments for Brain Tumors

Center Watch Clinical Trials Listing Service

You can use this site to find a wealth of information related to clinical trials, such as a listing of more than 41,000 industry- and government-sponsored clinical trials as well as new drug therapies recently approved by the FDA. Our site is designed to be a resource both for patients interested in participating in clinical trials and for research professionals.

The AEGIS Clinical Trial Wizard

Information about clinical trials, including trials by category, location, disease or condition, and more.

ClinicalTrials.gov

The U.S. National Institutes of Health, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members and members of the public current information about clinical research studies.

Drug Study Central

A great information source for clinical trials.

CCT - Current Controlled Trials

Current Controlled Trials is dedicated to promoting the exchange of information about controlled trials in all areas of healthcare.

ICSL Clinical Studies

ICSL Clinical Studies is one of the nation's leading clinical research organizations. Working in conjunction with pharmaceutical companies, we are committed to researching new medications for a wide range of illnesses and conditions.

Long Island Clinical Research Associates

Clinical research studies for gastrointestinal illnesses including GERD, IBD, and more. Contact Long Island Clinical Research Associates to participate in a trial and receive free treatment and test new medicines.

NHMRC Clinical Trials Center

The NHMRC Clinical Trials Center of the University of Sydney is a leader in clinical trials research in Australia, coordinating its own and assisting others in conducting large-scale, multi-center clinical trials. The Clinical Trials Center plays a vital role in promoting evidence based medicine in Australia.

ACT - About Clinical Trials

Here you will find easy-to-understand information about medical studies (also called "clinical trials") being run by ACT! Project research centers to test new treatments for various diseases. If you are ill, or know someone who is, we hope that you will find this web site useful in your search for new treatments. You don't need a medical degree to understand our information!

Last Revised : July, 2008

Disclaimer: PNA does not engage in the practice of medicine. It is not a medical authority, nor does it claim to have medical knowledge. In all cases, PNA recommends that you consult your own physician regarding any course of treatment or medication.

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