Status:
COMPLETED
Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Vaccines made from peptides and a person's white blood cells may help the body build an effective immune response to kill tumor cells. Injecting the vaccine directly into a lymph node may c...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility and safety of neoadjuvant ultrasound-guided intranodal vaccine therapy comprising autologous dendritic cells pulsed with recombinant HER2/neu peptides...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS) of the breast OR DCIS with microinvasion (\< 1 mm) by core biopsy or excisional biopsy
- HER2/neu positive tumor, defined as \> 10% of the tumor population expressing HER2/neu by immunohistochemical staining
- No evidence of invasive disease by MRI (performed within the past month)
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Sex
- Not specified
- Menopausal status
- Not specified
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- No thrombocytopenia (i.e., platelet count \< 75,000/mm\^3)
- No other coagulopathy
- Hepatic
- No hepatitis C positivity
- INR \> 1.5
- PTT \> 50 sec
- Renal
- Not specified
- Cardiovascular
- Ejection fraction ≥ 50% by MUGA or echocardiogram
- No major cardiac illness
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HIV positivity
- No toxicity \> grade 1
- No other pre-existing medical illness that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- Not specified
- Chemotherapy
- Not specified
- Endocrine therapy
- Not specified
- Radiotherapy
- No prior ipsilateral breast or axillary radiotherapy
- Surgery
- No prior ipsilateral axillary dissection
- No prior complete excisional biopsy for DCIS
- Other
- No other prior definitive treatment for DCIS
- No concurrent medications that would preclude study participation
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00107211
Start Date
January 1 2005
End Date
July 1 2008
Last Update
September 17 2014
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283