Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer

NCT00088985 | Terminated Phase 2 Results DMC

• 4 other identifiers: LCCC 0310P50CA058223R21CA105837KG100307
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Response measured by Response Evaluation Criteria In Solid Tumors (RECIST), (Complete Response + Partial Response) Complete Response (CR)- Disappearance of all target lesions Partial Response (PR)-at least a 30% decrease in the longest diameters of target lesions, taking as reference the baseline longest diameter.

  6 months following treatment

Secondary Outcomes (1)

• Immune Response

  3 months following treatment

Study Arms (1)

Dendritic Cell Vaccine

EXPERIMENTAL

Dendritic Cells: Dosage: 20 x 106 dendritic cells (DCs) given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly

Biological: therapeutic autologous dendritic cells; Biological: trastuzumab; Drug: vinorelbine ditartrate

Interventions

therapeutic autologous dendritic cells BIOLOGICAL

10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection

Dendritic Cell Vaccine

trastuzumab BIOLOGICAL

4 mg/kg intravenously, every 14 days

Dendritic Cell Vaccine

vinorelbine ditartrate DRUG

Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days

Dendritic Cell Vaccine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Locally recurrent or metastatic disease * HLA-A0201 positive by DNA genotyping * HER2/neu expression at least 1+ by immunohistochemistry of tumor sample * Central Nervous System (CNS) metastases allowed provided on therapy for 3 months and stable * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Hematocrit \> 33% Hepatic * Transaminases ≤ 3 times upper limit of normal * Bilirubin ≤ 2 times normal * Hepatitis B surface antigen negative Renal * Creatinine \< 2.0 mg/dL Cardiovascular * Ejection fraction \> 45% by multigated acquisition scan (MUGA) OR * Left ventricular function normal by echocardiogram * No serious cardiac condition that would preclude study participation or compliance Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No serious medical or psychiatric condition that would preclude study participation or compliance PRIOR CONCURRENT THERAPY: Biologic therapy * Prior biologic therapy allowed Chemotherapy * More than 30 days since prior cytotoxic chemotherapy * No other concurrent chemotherapy Endocrine therapy * More than 30 days since prior hormonal therapy * No concurrent hormonal therapy * No concurrent systemic steroids Radiotherapy * Not specified Surgery * Not specified Other * Concurrent bisphosphonates for bone metastases allowed

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Vinorelbine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Limitations and Caveats

Study was terminated due to unavailable funding.

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@UNC.med.edu

919-966-1125

Study Officials

• Jonathan S. Serody, MD

  UNC Lineberger Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2004
• First Posted: August 5, 2004
• Study Start: January 1, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 20, 2017
• Results First Posted: May 9, 2017

Record last verified: 2017-05

Locations

US (1)