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Biological Therapy in Treating Patients With Advanced Cancer

Primary Purpose

Breast Cancer, Gastric Cancer, Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HER-2/neu intracellular domain protein
therapeutic autologous dendritic cells
Sponsored by
Duke University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Safety
safety

Secondary Outcome Measures

Full Information

First Posted
July 5, 2000
Last Updated
July 7, 2014
Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005956
Brief Title
Biological Therapy in Treating Patients With Advanced Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
July 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Gastric Cancer, Ovarian Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
HER-2/neu intracellular domain protein
Other Intervention Name(s)
HER2 ICD
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Other Intervention Name(s)
DC
Primary Outcome Measure Information:
Title
Safety
Description
safety
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Morse, MD
Organizational Affiliation
Duke Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17822557
Citation
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.
Results Reference
result

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Biological Therapy in Treating Patients With Advanced Cancer

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