Oncophage Personalized Melanoma Vaccine

WHAT IS ONCOPHAGE?

Oncophage® (vitespen; formerly HSPPC-96) is an investigational personalized melanoma vaccine designed to treat melanoma with the intent of minimizing side effects. Oncophage is currently being investigated as a melanoma treatment and is only administered to patients in research studies.

The US Food and Drug Administration has designated Oncophage a fast track product for evaluation in the treatment of melanoma. Products are designated as fast track when they are intended to treat a serious medical condition and have the potential to address an unmet medical need.

HOW DOES ONCOPHAGE WORK?

Oncophage is a therapeutic vaccine made from individual patients’ tumors. Patients have surgery to remove part or all of the melanoma, and a portion of this tissue is sent to Antigenics (the company that makes Oncophage) so that the tumor-derived vaccine can be made.

Vaccines provoke the body’s natural disease-fighting response. A vaccine that is made from the patient’s own tumor is designed to contain the particular cancer’s ‘fingerprint.’ Injection of the Oncophage vaccine may cause the body to attack any cells bearing this cancer ‘fingerprint.’

WHAT’S THE DIFFERENCE BETWEEN ONCOPHAGE AND OTHER TREATMENTS?

Oncophage is different because it’s:

• A melanoma vaccine that may help your immune system fight your melanoma
• Personalized – it’s created from cells from your own body
• A therapy designed to target specific tumor cells only, thereby leaving healthy cells alone.

WHY IS ONCOPHAGE BEING STUDIED?

Oncophage is being studied to obtain useful information that may help future melanoma patients. It is also possible that if you are assigned to the experimental treatment group, Oncophage may have a favorable effect on your survival or may slow the progression of your cancer. However, it is not currently known whether treatment with Oncophage will result in a longer period of survival for patients with advanced melanoma.

HOW MANY PEOPLE HAVE RECEIVED ONCOPHAGE THERAPY?

More than 700 cancer patients around the world have been treated with Oncophage in clinical trials.

WHAT ARE THE SIDE EFFECTS OF ONCOPHAGE TREATMENT?

In clinical trials to date, reported adverse events (side effects) have been minimal.

WHAT WILL THIS STUDY BE TESTING?

The Phase 3 study will be comparing conventional treatment for melanoma versus treatment with the Oncophage vaccine.

Conventional Treatment	vs.	Oncophage Treatment
The conventional treatment for metastatic melanoma is any combination of cancer treatments, including surgery and/or interleukin 2 (immunotherapy) and/or DTIC-Dome or Temodar (chemotherapies).		Oncophage treatment includes surgery to remove all or part of the melanoma (which is used to make the personalized vaccine), followed by a series of Oncophage injections.

STUDY OF ONCOPHAGE IN METASTATIC MELANOMA (PROTOCOL C-100-21)
WHO will be tested?	More than 300 patients with stage IV melanoma
WHERE will the study take place?	At medical institutions in the United States, Europe and Australia
WHAT will the study be testing?	Current conventional treatment vs. Oncophage treatment
WHY is the study being done?	To see if Oncophage treatment is better than conventional treatment at prolonging survival

AM I ELIGIBLE FOR THE RESEARCH STUDY WITH ONCOPHAGE?

Potential candidates for the study are melanoma patients who have not received interleukin 2 immunotherapy or DTIC-Dome or Temodar chemotherapies. Your doctor can help to determine if this study is right for you.

IF I ENROLL IN THE STUDY, WILL I DEFINITELY RECEIVE ONCOPHAGE?

Patients enrolled in the study will be randomized (assigned by chance) to receive either Oncophage treatment (which includes surgery) or conventional treatment (your doctor’s choice of any treatment plan that includes surgery and/or interleukin 2 and/or chemotherapy). For every two patients who are assigned to receive Oncophage, one patient will be assigned to receive conventional treatment. That means that if you are enrolled in the study, there is a 67 percent chance that you will receive Oncophage.

WHAT IS TREATMENT WITH ONCOPHAGE LIKE?

Oncophage treatment begins after you’ve recovered from surgery (usually within four weeks). You receive one injection of your personalized Oncophage vaccine once a week for four weeks, then one Oncophage injection every other week. Oncophage treatment is designed to be given on an outpatient basis.

WILL USING ONCOPHAGE GUARANTEE THAT MY CANCER WON’T RETURN?

Using Oncophage is not a guarantee that your cancer will be cured or will not return.

WILL MY INSURANCE COVER THE COST OF PARTICIPATING IN THE STUDY?

While you are participating in the research study, any procedures that are required by the study protocol will either be covered by your insurance (as part of your usual medical care) or by Antigenics (the company that makes Oncophage). Talk with your doctor for more details.

HOW DO I ENROLL IN THE STUDY?

This trial is now closed to enrollment.

WHAT ARE SOME QUESTIONS I CAN ASK MY DOCTOR?

Your doctor is your best resource for information so you should feel free to ask any questions that are on your mind. Below are some questions you might want to ask your doctor.

• What stage is my disease? How far has the melanoma spread?
• What treatment choices do I have?
• What are the risks or side effects of different treatments?
• What treatment do you recommend and why?
• What is the goal of this treatment?
• What are the chances that the treatment will be successful?
• What should I do to prepare for treatment?
• How will we know if the treatment is working?
• How long will the treatment last?
• What can I do to take care of myself during treatment?
• What new treatments are being studied? Would a clinical trial be right for me?
• What are the chances of my cancer coming back with the treatment you suggest?
• Do I need follow-up appointments to check for recurrence or a new cancer?