Breast CancerNCT00005956
Biological Therapy in Treating Patients With Advanced Cancer
A study testing HER-2/neu intracellular domain protein and therapeutic autologous dendritic cells in people with Breast Cancer and Gastric Cancer, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Gastric Cancer, Ovarian Cancer
- What is being tested?
- HER-2/neu intracellular domain protein and therapeutic autologous dendritic cells
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Jul 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
About this study
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
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.
Read the 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
- Being tested
- HER-2/neu intracellular domain protein, therapeutic autologous dendritic cells
- 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
- Medical subject headings
- Breast Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HER-2/neu intracellular domain proteinBiological
Also called HER2 ICD
therapeutic autologous dendritic cellsBiological
Also called DC
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
safety
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2003 (estimated)
- Study startFeb 2000
- Primary completionAug 2001
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael A. Morse, MD, Study chair, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005956
- Sponsor's protocol ID
- 1309
- Other IDs
- 6542, 1528, CDR0000067937
- Status last verified
- Mar 2013
- First submitted
- 5 Jul 2000
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17822557
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00005956
- Acronym / sponsor ID
- 1309
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- Aug 2001 (actual)
- Study completion
- Jul 2002 (actual)
- First posted
- 21 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HER-2/neu intracellular domain proteinAlso: HER2 ICD | Biological | – |
| therapeutic autologous dendritic cellsAlso: DC | Biological | – |
Primary outcome
Safety
Time frame: 12 months
safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Results publication: PubMed 17822557Morse 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael A. Morse, MD study chair
Duke Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HER-2/neu intracellular domain protein and therapeutic autologous dendritic cells in people with Breast Cancer and Gastric Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005956, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2014.