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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


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Gastric Cancer, Ovarian Cancer

Thank you

Trial Information

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


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.

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.

PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.

Inclusion 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

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/mm^3

- Hemoglobin at least 9 mg/dL

- Platelet count at least 100,000/mm^3

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

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Outcome Description:

safety

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Michael A. Morse, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

1309

NCT ID:

NCT00005956

Start Date:

February 2000

Completion Date:

July 2002

Related Keywords:

  • Breast Cancer
  • Gastric Cancer
  • Ovarian Cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • stage II gastric cancer
  • stage III gastric cancer
  • stage IV gastric cancer
  • stage IIIB breast cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • Breast Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710