Clinical Trial - Vaccine Therapy in Treating Patients with DCIS of the Breast

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Vaccine Therapy in Treating Patients with Ductal Carcinoma in Situ of the Breast
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: June 17, 2009 Last Updated: July 9, 2009 History of Changes
Sponsor:University of PennsylvaniaCollaborator:National Cancer Institute (NCI)
Information provided by:National Cancer Institute (NCI)ClinicalTrials.gov Identifier:NCT00923143

Purpose RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying the side effects and best way to give vaccine therapy and to see how well it works in treating patients with ductal carcinoma in situ of the breast.

ConditionInterventionPhaseBreast Cancer
Biological: HER-2/neu peptide vaccine
Biological: therapeutic autologous dendritic cells
Phase I
Phase II

Study Type:InterventionalStudy Design:Allocation: Randomized
Primary Purpose: TreatmentOfficial Title:A Randomized Trial of HER-2/Neu Pulsed DC1 Vaccine for Patients With DCIS
Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

• <LI style="MARGIN-TOP: 0.7ex">Safety as assessed by NCI CTC v3.0 [ Designated as safety issue: Yes ]
• Immune response [ Designated as safety issue: No ]

Secondary Outcome Measures:

• <LI style="MARGIN-TOP: 0.7ex">Changes in HER2/neu molecular expression pre-and post-vaccination [ Designated as safety issue: No ]
  <LI style="MARGIN-TOP: 0.7ex">Clinical response [ Designated as safety issue: No ]
• Possible relationship between immune and clinical response and changes in HER2/neu molecular expression [ Designated as safety issue: No ]

Estimated Enrollment:57Study Start Date:March 2009Estimated Primary Completion Date:June 2013 (Final data collection date for primary outcome measure)

ArmsAssigned InterventionsArm I: Experimental Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally into 1-2 different normal groin or axillary lymph nodes once weekly for 6 weeks.
Interventions:

• Biological: HER-2/neu peptide vaccine
• Biological: therapeutic autologous dendritic cells

Biological: HER-2/neu peptidevaccine Given intranodally and/or intralesionally
Biological: therapeutic autologous dendritic cells Given intranodally and/or intralesionally
Arm II: Experimental Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intralesionally into the quadrant of the affected breast once weekly for 6 weeks.
Interventions:

• Biological: HER-2/neu peptide vaccine
• Biological: therapeutic autologous dendritic cells

Biological: HER-2/neu peptidevaccine Given intranodally and/or intralesionally
Biological: therapeutic autologous dendritic cells Given intranodally and/or intralesionally
Arm III: Experimental Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally and intralesionally as in arms I and II.
Interventions:

• Biological: HER-2/neu peptide vaccine
• Biological: therapeutic autologous dendritic cells

Biological: HER-2/neu peptidevaccine Given intranodally and/or intralesionally
Biological: therapeutic autologous dendritic cells Given intranodally and/or intralesionally

Detailed Description: OBJECTIVES:
Primary

• <LI style="MARGIN-TOP: 0.7ex">To establish the safety of HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine when administered via 3 different routes in patients with ductal carcinoma in situ of the breast.
• To establish the immune response rate in patients treated with this vaccine.

Secondary

• <LI style="MARGIN-TOP: 0.7ex">To evaluate changes in HER2/neu molecular expression pre- and post-vaccination. <LI style="MARGIN-TOP: 0.7ex">To evaluate the clinical response pre-and post-vaccination.
• To conduct exploratory analyses of possible relationships among these outcomes.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.
Patients undergo leukapheresis to obtain monocyte fractions for generation of the vaccine. The monocytes are cultured with GM-CSF, interleukin-4, interferon gamma, and lipopolysaccharide and pulsed with HER2/neu peptides for the production of type 1 dendritic cells.

• <LI style="MARGIN-TOP: 0.7ex">Arm I: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally into 1-2 different normal groin or axillary lymph nodes once weekly for 6 weeks. <LI style="MARGIN-TOP: 0.7ex">Arm II: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intralesionally into the quadrant of the affected breast once weekly for 6 weeks.
• Arm III: Patients receive HER2/neu peptide-pulsed autologous type 1 dendritic cell vaccine intranodally and intralesionally as in arms I and II.

Within 2-3 weeks after the completion of the last vaccination, patients undergo complete surgical excision (wide excision or mastectomy to negative margins) of their tumor.
After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.





Eligibility

Ages Eligible for Study: 18 Years and olderGenders Eligible for Study: BothAccepts Healthy Volunteers: NoCriteria
DISEASE CHARACTERISTICS:

• <LI style="MARGIN-TOP: 0.7ex">Histologically confirmed ductal carcinoma in situ (DCIS)
  • DCIS with evidence of microinvasion allowed
  <LI style="MARGIN-TOP: 0.7ex">HER2/neu-positive tumor, as defined by > 5% of tumor cells staining ≥ 2+ by Hercept (Dako) antibody testing <LI style="MARGIN-TOP: 0.7ex">No evidence of invasive breast cancer by MRI performed within the past 2 months
• Hormone-receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

• <LI style="MARGIN-TOP: 0.7ex">Menopausal status not specified <LI style="MARGIN-TOP: 0.7ex">ECOG performance status 0-1 <LI style="MARGIN-TOP: 0.7ex">Not pregnant or nursing <LI style="MARGIN-TOP: 0.7ex">Negative pregnancy test <LI style="MARGIN-TOP: 0.7ex">Fertile patients must use effective contraception <LI style="MARGIN-TOP: 0.7ex">Ejection fraction ≥ 50% by MUGA <LI style="MARGIN-TOP: 0.7ex">No major cardiac illness <LI style="MARGIN-TOP: 0.7ex">No coagulopathies, including any of the following:
  • <LI style="MARGIN-TOP: 0.7ex">Thrombocytopenia with platelet count < 75,000/mm^3 <LI style="MARGIN-TOP: 0.7ex">INR > 1.5
  • PTT > 50 sec
  <LI style="MARGIN-TOP: 0.7ex">No laboratory tests (including CBC, liver function tests, urinalysis, and EKG) reflecting > grade 1 toxicity, as assessed by NCI CTC v3.0, that cannot be corrected on repeat testing within 7 days <LI style="MARGIN-TOP: 0.7ex">No HIV or hepatitis C positivity
• No other pre-existing medical illness that may interfere with study participation

PRIOR CONCURRENT THERAPY:

• <LI style="MARGIN-TOP: 0.7ex">No prior definitive treatment for DCIS <LI style="MARGIN-TOP: 0.7ex">No prior complete excisional biopsy of the tumor
• No concurrent medications that may interfere with study participation

Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923143

Locations
United States, PennsylvaniaAbramson Cancer Center of the University of PennsylvaniaRecruitingPhiladelphia, Pennsylvania, United States, 19104-4283Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 Sponsors and Collaborators
University of Pennsylvania
National Cancer Institute (NCI)
Investigators
Principal Investigator:Brian J. Czerniecki, MD, PhDAbramson Cancer Center of the University of Pennsylvania


More Information
Additional Information: Clinical trial summary from the National Cancer Institute's PDQ® database




No publications provided

Responsible Party:Abramson Cancer Center of the University of Pennsylvania ( Brian J. Czerniecki )ClinicalTrials.gov Identifier:NCT00923143 History of ChangesOther Study ID Numbers:CDR0000644921, UPCC-15107, 807010Study First Received:June 17, 2009Last Updated:July 9, 2009Health Authority:Unspecified
Keywords provided by National Cancer Institute (NCI): ductal breast carcinoma in situ
HER2-positive breast cancer
male breast cancer


Additional relevant MeSH terms: Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary


ClinicalTrials.gov processed this record on January 31, 2011



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accine Therapy in Treating Patients with Ductal Carcinoma in Situ of the Breast