Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers

NCT00095862 | Terminated Phase 1

• 2 other identifiers: CDR0000393552WRI-GEV-007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Vaccines made from gene-modified tumor cells may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Combining vaccine therapy with cyclophosphamide and interferon alfa may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining vaccine therapy with interferon alfa and cyclophosphamide in treating patients who have stage IV breast cancer.

Conditions

Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

recurrent breast cancer; stage IV breast cancer; male breast cancer; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (5)

• Safety, tolerability, and feasibility

• Clinical response

• Time to progression

• Survival

• Correlation of clinical response with immunological response

Interventions

allogeneic GM-CSF-secreting breast cancer vaccine BIOLOGICAL

recombinant interferon alfa BIOLOGICAL

cyclophosphamide DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer meeting 1 of the following criteria: * Recurrent and/or metastatic lesions that are HER2/neu-positive or negative * Recurrent or progressive cancer of the lung, ovary, pancreas, prostate, bladder, or other primary site associated with HER2/neu-positive tumor by histochemistry * Bone-only metastatic breast cancer, cytologically confirmed malignant effusions, histologically confirmed marrow involvement, or other evaluable (but non-measurable) metastatic disease allowed * Failed prior first-line chemotherapy (e.g., anthracycline- or taxane-based therapy) with or without adjuvant chemotherapy or hormonal therapy * No curative or reliably effective palliative surgery, radiotherapy, or medical therapy available * Stable brain metastases allowed provided the following criteria are met\*: * Previously treated * No concurrent requirement for corticosteroids * No radiological or clinical deterioration within the past 6 weeks NOTE: \*Patients who had recent treatment with gamma knife or intensity-modulated radiotherapy for brain metastases are eligible provided there has been recovery from known or anticipated toxic effects * Patients with no HLA-A2 allele are eligible * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female or male Menopausal status * Not specified Performance status * ECOG 0-2 Life expectancy * At least 4 months Hematopoietic * Absolute granulocyte count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 2 mg/dL * Alkaline phosphatase ≤ 5 times upper limit of normal (ULN) * ALT and AST ≤ 2 times ULN Renal * BUN ≤ 30 mg/dL * Creatinine ≤ 2 mg/dL * ≤ 1 g protein on 24-hour urine collection OR * ≤ 1+ proteinuria on urinalysis Cardiovascular * Hypertension controlled by agents (except beta-blockers) allowed Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No history of anaphylactic reaction to any known or unknown antigen * No history of clinical hypersensitivity to sargramostim (GM-CSF), interferon, yeast, beef, or to any components used in preparation of study vaccine * No clinical or laboratory features indicative of AIDS * No rheumatological, psychiatric, or other clinically progressive major medical problems requiring treatment * No other malignancy within the past 2 years PRIOR CONCURRENT THERAPY: Biologic therapy * More than 3 weeks since prior biological therapy, including trastuzumab (Herceptin\^®) * More than 3 weeks since prior immunotherapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * More than 3 weeks since prior chemotherapy (8 weeks for nitrosoureas or mitomycin) * No concurrent chemotherapy Endocrine therapy * See Disease Characteristics * More than 3 weeks since prior hormonal therapy * No concurrent hormonal therapy * No concurrent systemic steroids * Concurrent inhalation steroids for respiratory hypersensitivity (e.g., triamcinolone nasal or pulmonary inhalers) allowed Radiotherapy * See Disease Characteristics * More than 3 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * More than 3 weeks since prior major surgery with general anesthesia * No concurrent major surgery Other * Recovered from prior therapy * Patients receiving pamidronate, bisphosphonates, or other supportive measures must continue therapy during study participation * No concurrent anticoagulants * No concurrent beta-blockers for control of mild hypertension or other indications

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

Sponsors & Collaborators

• Wiseman Research Initiatives LLC: lead

Study Sites (3)

Glendale Memorial Hospital Comprehensive Cancer Center

Glendale, California, 91204, United States

Location

Hollywood Presbyterian Medical Center

Los Angeles, California, 90027-0902, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Related Publications (1)

• Lacher MD, Bauer G, Fury B, Graeve S, Fledderman EL, Petrie TD, Coleal-Bergum DP, Hackett T, Perotti NH, Kong YY, Kwok WW, Wagner JP, Wiseman CL, Williams WV. SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes. Front Immunol. 2018 May 15;9:776. doi: 10.3389/fimmu.2018.00776. eCollection 2018.

  PMID: 29867922 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Interferon-alpha; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Charles L. Wiseman, MD, FACP

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: November 1, 2004
• Last Updated: February 5, 2018

Record last verified: 2011-10

Locations

US (3)