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.c The Associated Press

LOS ANGELES (AP) - World champion figure skater Scott Hamilton will undergo a high-tech radiation therapy for a non-cancerous brain tumor, his publicist said Thursday.

Hamilton, 46, will have gamma knife treatment later this month at The Cleveland Clinic in Ohio, said Dr. Gene Barnett, chairman of the clinic's brain tumor institute.

In the outpatient treatment, pinpoint doses of high radiation are delivered to kill the tumor while causing less damage to healthy tissue.

The treatment will take only a single visit but results usually are not known for at least a month.

"In Mr. Hamilton's case, he may need other minimally invasive procedures down the road to manage his tumor," Barnett said in a statement issued by the skater's publicist, Michael Sterling.

That is because the tumor has a fluid-filled cyst that can recur.

If that is the case, "it would need to be drained by using a chemical to reduce or stop fluid production." Barnett said.

Hamilton was diagnosed last month with a slow-growing, non-cancerous tumor in the region of his pituitary gland. In 1997, he was diagnosed with testicular cancer and treated with surgery and chemotherapy.

"Scott's spirit and confidence in Dr. Barnett, his staff, and the treatment, remain very high," Sterling said. "Needless to say, Scott is no stranger to adversity and has always faced every challenge in his life with great enthusiasm and an uncommon level of optimism."

Hamilton, who lives in Los Angeles, is a four-time U.S. national champion, a four-time world champion and the 1984 Olympic gold medalist. He is now a skating show producer.

Carmona: Steroid Abuse Is Health Concern

By SCOTT SONNER
.c The Associated Press

RENO, Nev. (AP) - The surgeon general said Monday he is greatly concerned about the impact of steroid use in the major leagues on young athletes who see professional baseball players as role models.

U.S. Surgeon General Richard Carmona also said leaders of other pro sports should examine whether their athletes are abusing steroids.

"From my standpoint, it is less a moral or ethical issue than it is a public health issue," Dr. Carmona told The Associated Press.

Steroids can cause a host of health problems, including organ failure and cancer.

"If youngsters are seeing their role models practicing this kind of behavior and it seems acceptable, then we need to do something about that because it is a health risk," he said.

The matter has been in the spotlight since the San Francisco Chronicle reported details last week of players' testimony to a federal grand jury that indicted four people on charges of illegally distributing steroids to top athletes.

One of those indicted was the personal trainer of the San Francisco Giants' Barry Bonds, whose 73 home runs in 2001 is the game's single-season record and who is 53 homers away from breaking Hank Aaron's all-time record of 755. Bonds told the grand jury he used a cream and a clear substance but said he didn't know they were forbidden substances.

Sen. John McCain, R-Ariz., said Congress should get involved if the league fails to act on its own and predicted President Bush would sign tougher prohibitions on steroid use.

"The important aspect of this issue is not Barry Bonds" or other big names, McCain, chairman of the Senate Commerce Committee, said on "Fox News Sunday."

"The important aspect of this issue is that high school kids all over America believe that this is the only way they can make it. Ask any high school coach."

Carmona said he has not decided whether Congress should get involved if Major League Baseball fails to enforce stronger rules against steroid abuse.

"As surgeon general, it is something that greatly concerns me but we need to get more of the facts first," he said before a speech in Reno at a "Fatherhood Summit."

Headline: HHS PURCHASES 1.2 MILLION DOSES OF FLU VACCINE GlaxoSmithKline Vaccine Adds To 61 Million Doses In United States

HHS Secretary Tommy G. Thompson announced today that the Food and Drug Administration authorized the use of GlaxoSmithKline influenza vaccine, Fluarix, in the United States under an Investigational New Drug application. Additionally, HHS has reached an agreement with the company to purchase 1.2 million doses of the vaccine for distribution to areas most in need.

This purchase is part of the Department's ongoing effort to identify and make available additional influenza vaccine doses to protect the American public for this winter's flu season. The doses of Fluarix vaccine are in addition to the existing supply of 61 million doses of licensed influenza vaccine, which includes about 58 million doses of Aventis injectable vaccine and 3 million doses of FluMist nasal spray.

"Our public health community has done an outstanding job of making sure the vaccine gets to those who need it most," Secretary Thompson said. "With this latest purchase, we will be able to protect more high-risk Americans this flu season in communities across the country."

Beginning this week, the Fluarix vaccine will be sent to the United States for distribution by the Centers for Disease Control and Prevention (CDC), based on the agency's determination of communities most in need. Fluarix has not been licensed for use in the United States and will be administered under an Investigational New Drug application (IND). The Fluarix vaccine being purchased by HHS has been approved by the European equivalents of the Food and Drug Administration (FDA), but is considered an IND because it is not currently licensed by FDA. The IND allows the investigational use of Fluarix, and HHS is immediately purchasing 1.2 million doses that are available this month. GlaxoSmithKline (GSK) has agreed to make up to 4 million doses available under the IND.

Under an IND, patients who are offered the Fluarix vaccine must sign an informed consent form that provides important information and acknowledges that they are aware of the potential adverse effects associated with the investigational vaccine. Sponsors of INDs are required to monitor the use of the investigational product, maintain adequate records, control the supply of product, provide periodic reports to FDA regarding safety and other issues and make sure informed consent is obtained from individuals before receiving the vaccine. CDC will assist GSK with these activities.

FDA has, over the past month, reviewed extensive manufacturing and clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine is suitable for use under an IND. FDA reviewed GSK's proposed clinical study plan and informed consent document, as well as the clinical protocol and manufacturing data. The IND mechanism can be used in this situation because there is not enough time or information to allow U.S. licensure. These steps along with the conditions and controls required under the IND are designed to assure the product is safe for use during the current flu season.

Additionally, the federal government has purchased and stockpiled antiviral medicines to treat more than 7 million people. Supplies of antiviral medicines also exist in the private sector and manufacturers indicate that they have the ability to significantly ramp up production. All told, between existing stockpiles, private sector supplies and production capabilities, the FDA estimates there could be enough medicine to treat tens of millions of people through the heart of flu season.

When President Bush and Secretary Thompson took office in early 2001, HHS spent just $39.3 million on flu surveillance, research, education and vaccine procurement activities. However, President Bush and Secretary Thompson aggressively moved HHS forward on flu-preparation activities, including producing the nation's first pandemic flu response plan, and an increase in spending to $283.1 million in fiscal year 2005.

HHS encourages those in high-priority groups to continue to check with their local health officials about availability of vaccine. Individuals who are having difficulty finding vaccine or who want additional information on influenza can call the CDC's hotline at 1-800-CDC-INFO. The high-priority groups include:

All children aged 6-23 months.
Adults aged 65 years and older.
People aged 2-64 years with underlying chronic medical conditions.
All women who will be pregnant during influenza season.
Residents of nursing homes and long-term care facilities.
Children 6 months to 18 years of age on chronic aspirin therapy.
Health-care workers with direct patient care.
Out-of-home caregivers and household contacts of children aged <6 months.

Finally, everyone can take practical steps to help prevent spread of flu, including:

Avoid close contact with people who are sick.
Keep your distance from others if you are sick.
When possible, stay home from work, school, and errands when you are sick, and don't send your children to child care or school if they are sick.
Cover your mouth and nose when coughing or sneezing.
Clean your hands often.

For more information about the flu, visit the CDC Web site: www.cdc.gov/flu.

Purpose

The study treatment period is 15 days in length and includes patients with pituitary Cushing’s disease who are candidates for surgical intervention as well as and patients who have recurrent Cushing’s post operatively.

Condition	Treatment or Intervention	Phase
Cushing's Syndrome	Drug: SOM230 s.c.	Phase II

MedlinePlus related topics:  Adrenal Gland Disorders
 

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title: A Multicenter, Open Label Study to Assess the Safety and Efficacy of 600 µg SOM230, Administered Subcutaneously, b.i.d. in patients with Cushing’s disease

Further Study Details: 

Expected Total Enrollment:  26

Study start: April 2004
 

Eligibility

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients with pituitary Cushing’s disease within the two months prior to study entry
• Patients for whom written informed consent to participate in the study has been obtained
• Female patients of child bearing potential who have not undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use barrier contraception throughout the course of the study, and for one month after the study has ended

Exclusion Criteria:

• Female patients who are pregnant or lactating
• Patients who have been previously treated with certain medications may be required to be without certain medications prior to entering the study
• Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or HgbA1C > 10
• Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or history of acute MI less than one year prior to the study entry or clinically significant impairment in cardiovascular function (e.g. blood pressure of 190/100mmHg or greater)
• Patients with chronic liver disease
• Patients with clotting disorders or abnormal blood counts
• History of immuno-compromise, including a positive HIV test result
• Patients with active gall bladder disease
• Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
• Patients with active malignant disease (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)

Location and Contact Information

Jesse Lee      862-778-2793    jesse.lee@pharma.novartis.com

California
      Cedars-Sinai Pituitary Center, Los Angeles,  California,  90048,  United States; Not yet recruiting

Shlomo Melmed, MD  310-423-4691 
Shlomo Melmed, MD,  Principal Investigator

Massachusetts
      Massachusetts General Hospital NE Unit, Boston,  Massachusetts,  02114,  United States; Not yet recruiting

Beverly Biller, MD  617-726-3870 
Beverly Biller, MD,  Principal Investigator

Pennsylvania
      University of Pennsylvania, Philadelphia,  Pennsylvania,  19104,  United States; Not yet recruiting

Peter Snyder, MD  215-898-0208 
Peter Snyder, MD,  Principal Investigator

France
      Service des Maladies, Paris,  75014,  France; Recruiting

Jerome Bertherat, MD  33 (0) 1 58411895 
Jerome Bertherat, MD, PhD,  Principal Investigator

Italy
      Clinical di Endocrinologia, Ancona,  Italy; Recruiting

Marco Boscaro, MD  39 071 5964740 
Marco Boscaro, MD,  Principal Investigator

United Kingdom
      Sir George E.Clark Metabolic Unit-Royal Victoria Hospital, Belfast,  United Kingdom; Recruiting

Brew Atkinson, MD   Ab.atkinson@royalhospitals.n-i.nhs.uk 
Brew Atkinson, MD,  Principal Investigator

More Information

Study ID Numbers:  CSOM230B2208
Record last reviewed:  July 2004
Record first received:  July 30, 2004
ClinicalTrials.gov Identifier:  NCT00088608
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-17

Trial Information

Summary: Cushing's Disease Study 2208

Novartis is conducting a study to assess the effectiveness and tolerability of multiple doses of a study drug in patients with Cushing’s disease.

Patients with a confirmed diagnosis of Cushing’s disease may be eligible for this study. Patients will self-administer the study drug via injections twice daily for 15 days. If after 15 days the investigator finds the treatment is providing benefit to the patients, they will be allowed to continue therapy. Patients may chose to stop therapy at any time.

Patients must meet all of the following criteria:

• Male or female patients 18 years or older
• Patients with Cushing’s disease which has been confirmed by a Doctor’s diagnosis and lab test results
• Ability to complete at least 15 days of study drug treatment
• Female patients must not be pregnant and must agree to use acceptable forms of birth control throughout the course of the study, and for one month after the study has ended

Patients will be excluded from the study for any of the following reasons:

• Have Cushing’s syndrome due to ectopic ACTH secretion
• Patients with hypercortisolism secondary to adrenal tumors or Nodular ( primary) bilateral adrenal hyperplasia
• Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
• Patient with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
• Patients who have thyroid malfunction
• Patients with the presence of active or suspected, acute or chronic, uncontrolled infection
• Patients who have undergone major surgery one month before starting the study
• Poorly controlled diabetes
• Patients who have cardiovascular problems (i.e. congestive heart failure, unstable angina, etc.),
• Patients with liver disease
• History of immuno-compromise, including a positive HIV test result.
• Patients with active gall bladder disease
• Patients with active malignant disease (with the exception of basal cell carcinoma)

For additional information about this trial click here.

Contact: Helen Peachey, Study Coordinator U Penn 778 Clinical Research Building 415 Curie Boulevard Philadelphia, PA 19104-6149 Telephone: 215-898-5664 Fax: 215-614-0418 Email: peacheyh@mail.med.upenn.edu

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If you would like to learn more about participating in this study, please send an e-mail message.

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This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

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We welcome your articles, letters to the editor, bios and Cushing's information. Submit a Story or Article to either the snailmail CUSH Newsletter or to an upcoming email newsletter at http://www.cushings-help.com/newsletter_story.htm

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Newest Bios:
To add or edit your bio, please click here.
Emily S.	Updated Emily is not yet diagnosed	Northern Kentucky
Kara	Kara is not yet diagnosed	Missoula, Montana
Merlenna H	Updated Merlenna met with the surgeon and has a tentative adrenal surgery date for Dec 20, 2004.	Dixon, California
R. Chandrashekar (rcshekar)	R. Chandrashekar had endoscopic pituitary surgery by nasal route on 01/09/2004, in India	Chennai, India
Susy	Susy is not yet diagnosed	Devon England

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• If you've been diagnosed with Cushing's, please participate in the Cushing's Register »

The information you provide will be used to create a register and will be shared with the medical world. It would not be used for other purposes without your expressed permission. Note: This information will not be sold or shared with other companies.

Lynne Clemens, Secretary of CUSH Org is be the person responsible for the creation of this register. If you have any questions you may contact her at lynnecush@comcast.net. You do not have to be a member of CUSH to fill out this questionnaire, as long as you are a Cushing’s patient. We do not believe that the world has an accurate accounting of Cushing’s patients. The only way to authenticate accuracy is with actual numbers. Your help will be appreciated. Thank you."

The new chatroom is available through http://www.cushings-help.com/chatroom.htm. Since this is our own room, you won't need to go into another area after first logging in. You'll be right there!

The very first time you go in, you will have to register for this chat. Although you may use your user name and password from the message boards, you will still need to register those before being allowed into the room.

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