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Phase I Pilot Study of HER2/neu Intracellular Domain Protein Pulsed Autologous Dendritic Cells in Patients With HER2/neu Expressing Advanced Malignancies Showing No Evidence of Disease After Standard Treatment
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outline Published Results Trial Contact Information Registry Information
Alternate Title
Biological Therapy in Treating Patients With Advanced Cancer
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase I
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Treatment
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Closed
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18 and over
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NCI
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DUMC-1309-00-7R1 DUMC-1528-99-9, NCI-G00-1800, NCT00005956
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Objectives - Evaluate the immune response of patients with HER2/neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2/neu intracellular domain protein pulsed autologous dendritic cells.
- Assess time to recurrence in these patients.
Entry Criteria Disease Characteristics:
- Histologically confirmed advanced malignancy that expresses HER2/neu
- Stage IIA breast cancer with more than 6 positive
lymph nodes
- Stage IIB, IIIA, or IIIB breast cancer
- Stage III ovarian cancer
- Lymph node positive gastric cancer
- Metastatic tumor
- No measurable or evaluable disease after standard treatment
- No previously irradiated or newly diagnosed CNS metastases
- Hormone receptor status:
Prior/Concurrent Therapy:
Biologic therapy: - No other concurrent immunotherapy
Chemotherapy: - At least 4 weeks since prior chemotherapy and
recovered
- No concurrent chemotherapy
Endocrine therapy: - Concurrent hormonal therapy allowed (tamoxifen, raloxifene,
toremifene, and all aromatase inhibitors)
- At least 4 weeks since prior steroid or immunosuppressive
therapy (e.g, azathioprine or cyclosporine)
Radiotherapy: - Prior radiotherapy allowed except to cranium
- At least 4 weeks since prior radiotherapy and
recovered
- At least 12 weeks since prior strontium chloride Sr
89
- No concurrent radiotherapy
Surgery: - At least 4 weeks since prior surgery and recovered
Other: - Concurrent bisphosphonates allowed
- No prior hepatitis B immunization
Patient Characteristics:
Age: Menopausal status: Performance status: Life expectancy: Hematopoietic: - WBC at least 3,000/mm3
- Hemoglobin at least 9 mg/dL
- Platelet count at least 100,000/mm3
Hepatic: - Bilirubin less than 2.0 mg/dL
- No hepatic disease, including viral hepatitis
Renal: - Creatinine less than 2.5 mg/dL
Cardiovascular: - No New York Heart Association class III or IV heart
disease
Pulmonary: - No asthma or chronic obstructive pulmonary disease
Immunologic: - Must have positive intradermal delayed hypersensitivity test
for at least 1 of the following:
- Candida
- Mumps
- Tetanus
- Trichophyton
- Histoplasmin
- No prior autoimmune disease including, but not limited to, the
following:
- Inflammatory bowel disease
- Systemic lupus erythematosus
- Ankylosing spondylitis
- Scleroderma
- Multiple sclerosis
Other: - Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- Hepatitis B surface antigen and hepatitis C antibody
negative
- No other concurrent serious chronic or acute illness or
infection (including urinary tract infection)
- No known shellfish or iodine allergy
- No other prior or concurrent malignancy except for nonmelanoma
skin cancer, cervical cancer, or controlled superficial bladder
cancer
- No medical or psychological condition that may preclude
study
Expected Enrollment A total of 6 patients will be accrued for this study over 6 months. Outline Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular
domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and
intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and
autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally
on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV
pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks
for a total of 4 courses in the absence of disease progression or unacceptable
toxicity. Patients are followed every 3 months for 1 year or until disease
progression. Published ResultsMorse MA, Hobeika A, Osada T, et al.: Long term disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer following vaccination against Her2. J Transl Med 5: 42, 2007.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations Duke Comprehensive Cancer Center ![](/images/spacer.gif) | ![](/images/spacer.gif) | ![](/images/spacer.gif) | Michael Morse, MD, Protocol chair | ![](/images/spacer.gif) | | ![](/images/spacer.gif) |
Registry Information | ![](/images/spacer.gif) | Official Title | | A Pilot Study of Active Immunotherapy with HER2/neu Intracellular Domain (ICD) Protein-Pulsed, Autologous, Cultured Dendritic Cells in Patients with No Evidence of Disease After Standard Treatment for HER2/neu Expressing Malignancies | ![](/images/spacer.gif) | Trial Start Date | | 2000-02-16 | ![](/images/spacer.gif) | Registered in ClinicalTrials.gov | | NCT00005956 | ![](/images/spacer.gif) | Date Submitted to PDQ | | 2000-05-03 | ![](/images/spacer.gif) | Information Last Verified | | 2003-03-24 | ![](/images/spacer.gif) | NCI Grant/Contract Number | | P30-CA14236 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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