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

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 18 and over NCI DUMC-1309-00-7R1 DUMC-1528-99-9, NCI-G00-1800, NCT00005956

Objectives

1. 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.
2. 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:
  • Not specified

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:

• 18 and over

Menopausal status:

• Not specified

Performance status:

• Karnofsky 80-100%

Life expectancy:

• Greater than 6 months

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.

Morse 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

Michael Morse, MD, Protocol chair		Ph: 919-681-3480

Registry Information
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
Trial Start Date		2000-02-16
Registered in ClinicalTrials.gov		NCT00005956
Date Submitted to PDQ		2000-05-03
Information Last Verified		2003-03-24
NCI Grant/Contract Number		P30-CA14236

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