Biological Therapy in Treating Patients With Advanced Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005956
• Other study ID #: 1309
• Secondary ID: 65421528CDR00000
• Status: Completed
• Phase: N/A
• First received: July 5, 2000
• Last updated: July 7, 2014
• Start date: February 2000
• Est. completion date: July 2002

Study information

• Verified date: March 2013
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: July 2002
• Est. primary completion date: August 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Gastric Cancer
• Ovarian Cancer
• Stomach Neoplasms

Intervention

Biological:
• HER-2/neu intracellular domain protein

• therapeutic autologous dendritic cells

Locations

Country	Name	City	State
United States	Duke Comprehensive Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Morse MA, Hobeika A, Osada T, Niedzwiecki D, Marcom PK, Blackwell KL, Anders C, Devi GR, Lyerly HK, Clay TM. Long term disease-free survival and T cell and antibody responses in women with high-risk Her2+ breast cancer following vaccination against Her2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	safety	12 months	Yes