KTVU Video Bay Area People #1014 Interview by Rosy Chu entitled "Melanoma Trials" at the Northern California Melanoma Center, San Francisco.

		ABC News 7 Video "Genomic Medicine May Revolutionize Melanoma Treatments" at the Northern California Melanoma Center, San Francisco. Note: video has pre-roll advertisement Click for full article

A NEW TRIAL IS OPEN! This week the Northern California Melanoma Center started enrolling patients in a new clinical trial for melanoma. The study is for patients with melanoma whose disease has progressed following initial (First-Line) therapy for metastatic disease.

Patients who meet eligibility criteria and agree to participate undergo a screening process and then are randomized on a 2:1 basis to receive the study drug, OncoVEX or GM-CSF (granulocyte macrophage colony stimulating factor), a drug that boosts immune responses. OncoVEX is a virus that is injected into tumor tissue where it enters the malignant cells and kills them while not harming normal cells. It also is engineered to release GM-CSF at the tumor site, with the goal of boosting the patient's immune responses to their own tumor, thereby helping to kill cancer cells in distant metastases.

The initial data from the Phase I and II trials has been promising. Additionally, this type of treatment is less toxic and has fewer serious side effects than other treatments that are often used in this setting such as chemotherapy, combinations, or other biologic therapy, such as IL-2 (interleukin-2).

To read a description of the trial, as well as inclusion criteria, click here: http://www.melanomacenter.com/whatis/mel_prots_oncovex.gm_csf.html

For further in formation about this or any of our clinical trials, please contact the Northern California Melanoma Center at (415) 750-5660.

I just returned from the International Conference on melanoma held in Vienna. Here's the latest on the AJCC/UICC Staging System to be released in 2009. You might want to check out the Website on Individualized Melanoma Patient Outcome Prediction Tools developed by Seng-jaw Soong et al, referenced below. It's pretty cool!

The major change in the 2009 AJCC/UICC Melanoma Staging System is the inclusion of mitotic activity in the primary as important prognostic factor. Mitotic activity is histologically defined as mitoses/mm2. A mitotic rate equal of greater than 1/mm2 denotes a melanoma at higher risk for metastasis. A test version of a program to determine the 5- and 10- year survival for an individual patient is available on the following Website: www.melanomaprognosis.org. For patients with localized melanoma (Stage I/II melanoma), the significant prognostic factors were found to be gender, age, lesion site, tumor thickness, and ulceration and these are included in the predictive model. For patients with regional metastasis (Stage III melanoma), the significant factors were the same, with the added factors of tumor burden and number of nodes involved with melanoma. The Website allows one to insert these significant prognostic factors for an individual patient and it will use these factors to report estimated 5- and 10- year survival rates and confidence intervals.

Lynn Spitler

As requested, here are the updated Melanoma Patient Web Resources & Links 1.19.09 all with clickable web links. This shall be updated shortly. Thanks. Spitler

American Society of Clinical Oncology, Melanoma melanomaca.asco.org
ASCO www.asco.org
Macmillan Cancer Support www.macmillan.org.uk
Cancer.Net www.cancernet.net
ClinicalTrials.gov www.clinicaltrials.gov
Medline Plus www.nlm.nih.gov/medlineplus
Sydney Melanoma Unit, The University of Sydney, Australia www.surgery.usyd.edu.au
Melanoma Patients' Information Page MPIP www.mpip.org
Melanoma Research Foundation www.melanoma.org
Melanoma International Foundation www.melanomaintl.org
Melanoma Molecular Map Project MMMP www.mmmp.org
National Cancer Institute (US) - Melanoma
www.cancer.gov
National Library of Medicine, Pub Med www.pubmed.gov
Northern California Melanoma Center www.NCMC.com
OncoLink www.oncolink.org
Skin Cancer Foundation www.SkinCancer.org
The Melanoma Blog www.themelanomablog.com

EORTC 18961: Post-operative adjuvant ganglioside GM2-KLH21 vaccination treatment vs observation in stage II (T3-T4N0M0) melanoma: 2nd interim analysis led to an early disclosure of the results.

• Abstract No: 9004
• Citation: J Clin Oncol 26: 2008 (May 20 suppl; abstr 9004)
• Author(s): A. M. Eggermont, S. Suciu, W. Ruka, J. Marsden, A. Testori, P. Corrie, S. Aamdal, P. A. Ascierto, P. Patel, A. Spatz, EORTC Melanoma Group

Abstract
Background: EORTC 18961 assessed in the largest adjuvant phase III trial to date in stage II melanoma the efficacy and toxicity of Ganglioside GM2-KLH21 Vaccination (VAC) Treatment vs Observation (OBS).

Methods
Patients (Pts)\ were observed or received vaccine sc once weekly week 1-4, every 3 months from week 12 for first 2 years and every 6 months during third year (total of 14 vaccinations).

Stratification Factors for Randomization
Breslow thickness, ulceration, being staged yes vs no by Sentinel Node (SNLD) or Elective Lymph Node Dissection (ELND), sex and institution.

Relapse-free survival (RFS) was the primary endpoint; Distant metastasis-free survival (DMFS) and overall survival (OS) were the prespecified secondary endpoints.

Intent-to-treat analysis was performed.

Results

• Between March 2002 and Dec. 2005, 1,314 pts entered the trial.
• Patient demographics showed perfect balance for prognostic factors.
  
• The 2nd interim analysis was performed when 267 RFS events were reported, i.e. 67% of the total number required at final analysis.
  
• Median follow-up was 1.8 years.
  

Similar Treatment Differences

• Obtained in lympnhnode-staged (N=644) or non-staged (N=670) patients.
• Grade 3 - toxicities occurred in < 2%.(VAC) and in < 1% (OBS).
• Grade 2 - toxicities comprised fatigue (15% vs 3%), fever (9% vs 1%), nausea (3% vs 1%).
  
• Local grade 3 - toxicity occurred in 4 % (VAC).
  
• The EORTC IDMC reviewed both safety and efficacy data.
  
• For the primary endpoint, RFS, the criteria for stopping for futility were met. 
• For DMFS and OS, the results pointed in the direction of a detrimental effect of the vaccine.
  

The IDMC recommended trial 18961 to be stopped and vaccinations to be halted in pts still receiving VAC. Pts should continue to be followed for the trial's endpoints.

Conclusions
Adjuvant GM2-KLH21 vaccination is ineffective and could even be detrimental in stage II melanoma patients.

Two upcoming events for people living with cancer, their loved ones and friends, and health professionals. Presented by Jeremy Geffen, MD, FACP

• April 25-27, 2008: Weekend Workshop, Naropa University, Boulder, CO
• June 5-8, 2008: Four Day Retrea, SpiritPath at Unity Village, Unity Village, MO

More details: http://www.geffenvisions.com/