Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Ductal Carcinoma In Situ of the Breast

NCT00107211 | Completed Phase 1 DMC

• 3 other identifiers: CDR0000416200UPCC-08102UPCC-704447
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 cause a stronger immune response and kill more tumor cells. Giving vaccine therapy before surgery may be effective treatment for ductal carcinoma in situ of the breast. PURPOSE: This phase I trial is studying the side effects and best way to give vaccine therapy in treating patients who are undergoing surgery for ductal carcinoma in situ of the breast.

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situ; breast cancer in situ

Interventions

therapeutic autologous dendritic cells BIOLOGICAL

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Brian J. Czerniecki, MD, PhD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 5, 2005
• First Posted: April 6, 2005
• Study Start: January 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

US (1)