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Investigator(s):
Lauren V. Wood, M.D. Principal Investigator Phone: 301-402-0199 Fax: 301-480-8437 woodl@mail.nih.gov	Jay A. Berzofsky, M.D., Ph.D. Lead Associate Investigator Phone: 301-496-6874 Fax: 301-480-0681 berzofsk@helix.nih.gov
Referral Contact(s):
Brenda Roberson, R.N., O.C.N. Nurse Specialist, Research Clinical Trials Coordinator Phone: 301-435-4733 Fax: 301-480-0282 broberson@mail.nih.gov

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Key Eligibility Criteria:

• Part I
• Diagnosis of one of the following:
• Recurrent or progressive metastatic solid tumors characterized by some HER2/neu expression that have failed standard therapies with known benefit but for whom trastuzumab is not clinically indicated:
• Patients with ovarian, colon, non-small cell lung, renal cell, bladder, or prostate cancer that is known to be HER2 1+, 2+, or 3+ by IHC OR have a Vysis FISH result > 1.8
• Patients with breast cancer that is known to be HER2 1+ or 2+ by IHC or with a Vysis FISH result of 1.8 - < 2.2
• HER2+ bladder cancer in the adjuvant setting (adjuvant bladder cancer patients)
• Tumor stage T3a, T3b, T4a, and T4b and any node-positive disease regardless of tumor stage
• Tumors that are HER2 1+, 2+, or 3+ by IHC or have a Vysis FISH result > 1.8
• Status ≥ 6 weeks post primary cystectomy with curative intent
• May or may not have received neodjuvant cisplatin-based combination chemotherapy or adjuvant radiotherapy or chemotherapy based on pathologic risk per NCCN guidelines
• Presence of measurable disease defined by at least one lesion that can be accurately measured by CT scan or measurable, clinically visible skin lesions*
• No previous treatment with trastuzumab, pertuzumab, lapatinib, or other investigational HER2-directed therapies (e.g., TDM-1)
• Baseline LVEF by 2D Echocardiogram ≥ 55 percent

• Part II
• Diagnosis of breast cancer with 3+ HER2/neu expression by IHC or a Vysis FISH result > 2.2
• Recurrent or progressive metastatic disease
• Disease progression following 1–2 courses of treatment with known clinical benefit (i.e., trastuzumab, pertuzumab, lapatinib, or other investigational HER2 agents [e.g., TDM-1, MGAH22])
• Presence of measurable disease defined by at least one lesion that can be accurately measured by CT scan and/or measurable, clinically visible skin lesions
• Baseline LVEF by 2D Echocardiogram ≥ 55 percent

* With the exception of metastatic bladder cancer patients who have completed first-line chemotherapy and may not have measurable disease.

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Study Outline:

• Screening visit includes physical examination and medical history, blood samples, and imaging studies to determine eligibility for the study
• Apheresis procedure to collect patient’s own white blood cells that will be used to generate the vaccine
• Following successful generation of vaccine, dendritic cell vaccine will be given intradermally (just under the skin) at Weeks 0, 4, 8, and 24
• Follow-up clinic visits for physical exam, lab draws at Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 48, 52, 76, 100, and 124; diagnostic scans at Weeks 0, 8, 12, 16, 20, 24, 28, 36, 40, 48, and 52
• Adjuvant bladder cancer patients will undergo re-staging for evidence of disease recurrence (with confirmatory scans 4 weeks later if recurrence is documented) at Weeks 12, 20, 28, 40, and 52

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.

Reviewed: 
Updated: 1/30/13