Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases.


Recurrent chest wall disease and isolated skin metastases are difficult to treat. Imiquimod, a small molecule immune response modifier, generates an immune signal similar to that of pathogenic bacteria, triggering immune activation. Abraxane, a new taxane formulation, also has immunostimulatory effects. We hypothesize the chemotherapy-associated immunologic effects could potentially synergize and augment the anti-tumor effect of imiquimod.


~Population~

Patients with advanced stage breast cancer with measurable chest wall disease and/or cutaneous metastatic lesions


~Treatment~

Abraxane on days 1, 8, 15 of a 28 day cycle & self application of imiquimod weekly on days 1-4


~Objectives~

Safety & anti-tumor effects of chemo-immunotherapy


~Visits~

Weekly visits for 13 weeks plus 3 monthly visits


~Information~

Call Nicole Bates at the TVG: 206.543.6620

Dear Friends of the TVG,

Dr. Lupe Salazar and I recently had the privilege to attend and present research at the 2009 American Society of Clinical Oncologists (ASCO) Annual Meeting in Orlando, FL. The meeting spanned five days and provided a forum for physicians, scientists, and cancer advocates to learn about the latest advances in cancer research and care. The Tumor Vaccine Group was proud to present five research abstracts, ranging from vaccine studies to our work in adoptive T cell therapy:

A phase I study of a DNA plasmid based vaccine encoding the HER-2/neu (HER2) intracellular domain (ICD) in subjects with HER2+ breast cancer We analyzed dosing arms 1 (10ug) and 2 (100ug) of a three-arm study and concluded that this vaccine is safe for patients at these doses. 13/21 (62%) research patients in Arm 1 developed T-cell immunity. Analysis for Arm 2 is still ongoing. Abstract number: 3054

Persistent immunity and survival after immunization with a HER-2/neu (HER2) vaccine New immune tests done on stage III and IV patients who were vaccinated between 1996 and 1999 demonstrate that active immunization is durable years after vaccination. The generation of epitope spreading (ES) is an independent predictor of overall survival: median overall survival for patients with ES (n=33) was 84 months, versus 25 months for patients without ES (n=16). Abstract number: 3010

Development of HER-2/neu (HER2) specific T cell immunity in patients with HER2+ inflammatory breast cancer (IBC) may impact prognosis Dr. Salazar found that 12/18 inflammatory breast cancer subjects (66%) who were evaluated for immunologic response after vaccination generated HER2 specific T cell immunity and had a longer overall survival rate compared to historical controls. Abstract number: 3057

Phase I study of infusion of HER-2/neu (HER2) specific T cells in patients with advanced stage HER2 overexpressing cancers who have received a HER2 vaccine Results from the first arm of this two-arm study indicate that the adoptive transfer of autologous HER2 specific polyclonal T cells generated from PBMC after vaccine-priming is well tolerated in patients with advanced stage HER2+ cancers. Three of five patients showed a clinical response (two with partial responses, one with stable disease), and their immunity to HER2 augmented over time. Abstract number: 3000

The level of HER-2/neu (HER2) gene amplification in breast cancer impacts the magnitude of antigen specific T cell immunity achieved after HER2 vaccination Our data show that the level of HER-2/neu (HER2) gene amplification in breast cancer impacts the magnitude of antigen specific T cell immunity achieved after HER2 vaccination. Abstract number: 3059

You can learn more about any of these research findings by searching for the abstract numbers at www.asco.org. To all the patients who took part in these trials, thank you: we couldn’t have done this work without you!

Sincerely,

Mary L. (Nora) Disis, MD
Tumor Vaccine Group Founder and Director