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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, tolerability, and feasibility

Safety Issue:

Yes

Principal Investigator

Charles L. Wiseman, MD, FACP

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

CDR0000393552

NCT ID:

NCT00095862

Start Date:

November 2004

Completion Date:

Related Keywords:

  • Breast Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • recurrent breast cancer
  • stage IV breast cancer
  • male breast cancer
  • unspecified adult solid tumor, protocol specific
  • Breast Neoplasms

Name

Location

Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, California  91204
Fountain Valley, California  92708
Hollywood Presbyterian Medical CenterLos Angeles, California  90027-0902