Biological Therapy in Treating Patients With Advanced Cancer

NCT ID: NCT00005956

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2002-07-31

Brief 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.

Detailed 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.

Conditions

Breast Cancer; Gastric Cancer; Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

HER-2/neu intracellular domain protein

Intervention Type: BIOLOGICAL

therapeutic autologous dendritic cells

Intervention Type: BIOLOGICAL

Other Intervention Names

HER2 ICD; DC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael A. Morse, MD

Role: STUDY_CHAIR

Duke Cancer Institute

Locations

Duke Comprehensive Cancer Center

Durham, North Carolina, United States

Countries

United States

References

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. J Transl Med. 2007 Sep 6;5:42. doi: 10.1186/1479-5876-5-42.

Reference Type: RESULT

PMID: 17822557 (View on PubMed)

Other Identifiers

6542

Identifier Type: OTHER

Identifier Source: secondary_id

1528

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000067937

Identifier Type: OTHER

Identifier Source: secondary_id

1309

Identifier Type: -

Identifier Source: org_study_id