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Protocol Details

A Phase I Study of an Adenoviral Transduced Autologous Dendritic Cell Vaccine Expressing Human HER2/neu ECTM in Adults with Tumors with 1-3+ HER2/neu Expression

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required


Population Exclusion(s)

Pregnant Women;


Metastatic Solid Tumors;
Human Epidermal Growth Factor Receptor 2 Expression (HER2/neu);
Trastuzumab Exposure;
Dendritic Cell Vaccine;
Breast Cancer

Recruitment Keyword(s)



Breast Neoplasms;
Breast Cancer;
Metastatic Solid Tumors Characterized by HER2/Neu Expression

Investigational Drug(s)

Ad5f35HER2ECTM transduced autologous dendritic cell vaccine

Investigational Device(s)



Biological/Vaccine: Adenoviral Transduced Autologous Human Epidermal Growth Factor Receptor (AdHER)2/neu Dendritic Cell (DC) Vaccine

Supporting Site

National Cancer Institute


- Human epidermal growth factor receptor 2 (HER2, also known as c-erbB2 or neu)/neu (HER2) is a tumor protein that appears in almost a third of breast cancers and in several other types of cancers such as colon, prostate and non-small cell lung. Tumors that overexpress HER2 can be associated with a more aggressive cancer, higher recurrence rates, and reduced survival rates. Researchers are testing a therapeutic cancer vaccine designed to stimulate the immune system to recognize HER2. The vaccine, called adenoviral transduced autologous human epidermal growth factor receptor (AdHER)/neu dendritic cell vaccine, is custom-made using an individual's own immune cells. These cells will be collected and used to produce the vaccine.


- To test the safety and effectiveness of AdHER2 vaccination.


- Individuals at least 18 years of age who have HER2-expressing tumors.


-Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies will also be performed.

-Participants will have an apheresis procedure to collect immune cells to create the vaccine.

-Participants will receive five doses of the vaccine at study Weeks 0, 4, 8, 16 and 24.

Participants will be monitored with physical exams, frequent blood tests and imaging studie-s.

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Common Eligibility for Parts I and II

-Adults greater than or equal to 18 with malignant soft tissue and bone tumors and recurrent or progressive,metastatic solid tumors who have progressed on standard therapies except in adjuvant for high risk bladder cancer in Part I.

- Recurrent or progressive disease on prior standard therapies with known clinical benefit with the exception of adjuvant bladder cancer population.

-Performance Status: ECOG 0-1.

-Baseline LVEF by 2D Echocardiogram greater than or equal to 53%.

-Greater than or equal to 1 week since standard or investigational treatment for metastatic disease.

-Stable, concurrent use of hormone therapy for hormone receptor positive breast cancer is permitted.

-Hematologic parameters: ANC greater than or equal to 1000 cells/mm3, ALC greater than or equal to 300 cells/mm3, Hemoglobin greater than or equal to 9.0 gm/dL, WBC greater than or equal to 2,500 cells/mm3, platelet count greater than or equal to 75,000/mm3, PT/PTT less than or equal to 1.5X the upper limits of normal.

-Chemistry parameters: Creatinine less than or equal to 1.5 mg/dL, SGOT and SGPT less than or equal to 3X the upper limits of normal and total bilirubin less than or equal to 1.5 mg/dl, Alk PO4 less than or equal to 3X the upper limits of normal (except for patients with documented metastatic disease to bone and/or liver).

-Negative serum beta HCG if female and of childbearing potential.

-Negative HIV 1/2 serology and sample drawn for HTLV. Patients with HIV are excluded from participating on this clinical trial because their immunodeficiency would confound the evaluation of adverse events which would hinder meeting the primary objective.

- Negative serology for hepatitis B and C unless the result is consistent with prior vaccination or prior infection with full recovery.

-Willingness of female and male subjects to use effective contraception e.g. oral contraceptives, barrier device, intrauterine device, or condoms, during the study and for three months following the last dose of study vaccine. We suggest that subjects do not become pregnant or father a child during the study, and for 3 months following receipt of the investigational AdHER2 DC vaccine.

-Able to understand and provide Informed Consent.

-Patients with 1+ to 3+ HER2/neu expression by IHC or an equivocal or positive FISH result by 2013 ASCO/CAP guideline.

-Patients must have measurable disease, per RECIST 1.1.

Part I Eligibility

- Naive to trastuzumab (Herceptin), pertuzumab (Perjeta) and lapatinib (Tykerb),ado-trastuzumab emtansine (Kadcyla) or other HER2-directed therapies.

- Malignancy as follows:

-Malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid tumors who have progressed on standard therapies; or,

-Bladder cancer in the adjuvant setting (adjuvant bladder cancer patients):

--Tumor stage T3a, T3b, T4a, T4b and any node positive disease regardless of tumor stage.

--Status-post primary cystectomy with curative intent.

--May or may not have received neoadjuvant cisplatin-based combination chemotherapy per NCCN guidelines.

--May or may not have received adjuvant radiotherapy or chemotherapy based on pathologic risk per NCCN guidelines.

--Greater than or equal to 6 weeks s/p primary surgery with curative intent.

-NOTE: Patients with breast, ovarian, cervical, colon, gastric/gastroesophageal junction, non-small cell lung, renal cell, bladder, malignant soft tissue and bone tumor, prostate cancer or other solid tumors.

Part II Eligibility

-Malignant soft tissue and bone tumors and recurrent or progressive, metastatic solid tumors who have progressed on standard therapies.

-Recurrent or progressive metastatic disease after standard of care HER2-targeted therapies; i.e. trastuzumab (Herceptin), pertuzumab (Perjeta), lapatinib (Tykerb),

ado-trastuzumab emtansine (TDM1) (Kadcyla) or other HER2-directed therapies.

-Stable, concurrent use of tamoxifen or aromatase inhibitors for hormone receptor positive breast cancer is permitted.


-Pregnant women are excluded from this study because AdHER DC vaccine may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AdHER DC vaccine, breastfeeding should be discontinued if the mother is treated with AdHER DC vaccine.

- Patients with active CNS metastases or leptomeningeal involvement by tumor (patients with a history of brain metastases who have successfully treated for brain metastasis by surgery or radiation and who have not had any evidence of the new or progressive CNS disease for more than 12 months are eligible).

-Patients with rapidly progressing disease in the opinion of the Principal Investigator.

-Patients with inadequate bilateral peripheral venous or central venous catheter access for the required apheresis to allow generation of the autologous AdHER2 DC vaccine product.

-Clinically significant cardiac dysfunction defined as a history of > NYHA Class II symptoms, angina, congestive heart failure, myocardial infarction, arrhythmias or cardiac dysfunction requiring treatment or discontinuation of chemotherapy.

- History of changes in baseline LVEF that occurred during prior treatment with anti-HER2 treatment.

-Cumulative doxorubicin dose > 400mg/m2 (>450 mg/m2 for malignant soft tissue and bone tumor patients) or cumulative epirubicin dose > 800mg/m2.

-Use of any standard chemotherapy or other investigational agent(s) within 1 week of study enrollment.

-Use of systemic corticosteroid therapy within 2 weeks of study enrollment, including patients receiving replacement corticosteroid therapy. Note: only topical, inhaled and intranasal steroid therapy is permitted.

-Active systemic viral, bacterial or fungal infection requiring treatment.

-A medical history which the treating physician believes causes the patient to be excluded. This includes a remote history of cancer. Please note: squamous cell carcinoma, basal cell carcinoma and remote history of cancer with no evidence of recurrence for the past 5 years are eligible.

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Moasser MM. The oncogene HER2: its signaling and transforming functions and its role in human cancer pathogenesis. Oncogene. 2007 Oct 4;26(45):6469-87. Epub 2007 Apr 30.

Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF; American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol. 2007 Jan 1;25(1):118-45. Epub 2006 Dec 11.

Lan KH, Lu CH, Yu D. Mechanisms of trastuzumab resistance and their clinical implications. Ann N Y Acad Sci. 2005 Nov;1059:70-5.

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Principal Investigator

Referral Contact

For more information:

Hoyoung M. Maeng, M.D.
National Cancer Institute (NCI)
(240) 781-3253

Hoyoung M. Maeng, M.D.
National Cancer Institute (NCI)
(240) 781-3253

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office

Clinical Trials Number:


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