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

Primary Purpose

Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
allogeneic GM-CSF-secreting breast cancer vaccine
recombinant interferon alfa
cyclophosphamide
Sponsored by
Wiseman Research Initiatives LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer, male breast cancer, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Glendale Memorial Hospital Comprehensive Cancer Center
  • Hollywood Presbyterian Medical Center

Outcomes

Primary Outcome Measures

Safety, tolerability, and feasibility
Clinical response
Time to progression
Survival
Correlation of clinical response with immunological response

Secondary Outcome Measures

Full Information

First Posted
November 9, 2004
Last Updated
February 1, 2018
Sponsor
Wiseman Research Initiatives LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00095862
Brief Title
Vaccine Therapy in Treating Patients With HER2/Neu Positive or Negative Stage IV Breast Cancer or Other HER2/Neu Positive Cancers
Official Title
A Phase 1-2 Study for Stage IV Breast and HER2/Neu Positive Cancers to Evaluate the Safety and Efficacy of a Vaccine Using Whole Cells From the SVBR- 1-GM Cell Line Genetically Engineered To Produce Granulocyte- Macrophage Colony Stimulating Factor
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Terminated
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Wiseman Research Initiatives LLC

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Determine the safety, tolerability, and feasibility of vaccine therapy comprising an allogeneic (non-self) tumor cell line transfected with the sargramostim (GM-CSF) gene combined with low-dose interferon alfa and low-dose cyclophosphamide in patients with stage IV breast cancer or other solid tumors. Determine the clinical response, time to progression, and survival of patients treated with this regimen. Correlate clinical response with immunological response in patients treated with this regimen. OUTLINE: Patients receive low-dose cyclophosphamide IV once 2-3 days before each tumor vaccine. Patients then receive tumor vaccine comprising HER2/neu-positive allogeneic (non-self) breast cancer cells transfected with the sargramostim (GM-CSF) gene intradermally (ID) on day 1. Patients also receive low-dose interferon alfa ID approximately 48 and 96 hours after each tumor vaccine. Treatment repeats every 2 weeks for 3 vaccinations and then monthly for 3 vaccinations in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
allogeneic GM-CSF-secreting breast cancer vaccine
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Primary Outcome Measure Information:
Title
Safety, tolerability, and feasibility
Title
Clinical response
Title
Time to progression
Title
Survival
Title
Correlation of clinical response with immunological response

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles L. Wiseman, MD, FACP
Official's Role
Study Chair
Facility Information:
Facility Name
Glendale Memorial Hospital Comprehensive Cancer Center
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Hollywood Presbyterian Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027-0902
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35593340
Citation
Wiseman CL, Kharazi A, Sunkari VG, Galeas JL, Dozio V, Hashwah H, Macuchova E, Williams WV, Lacher MD. Regression of Breast Cancer Metastases Following Treatment with Irradiated SV-BR-1-GM, a GM-CSF Overexpressing Breast Cancer Cell Line: Intellectual Property and Immune Markers of Response. Recent Pat Anticancer Drug Discov. 2022;18(2):224-240. doi: 10.2174/1574892817666220518123331.
Results Reference
derived
PubMed Identifier
29867922
Citation
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.
Results Reference
derived

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

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