Breast Cancer Clinical Trial
Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Giving a vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy when given together with Montanide ISA-51 and sargramostim in treating patients with stage IV breast cancer.
Full Description
OBJECTIVES:
Primary
Determine the safety of telomerase: 540-548 peptide vaccine emulsified in Montanide ISA-51 and sargramostim (GM-CSF) in patients with HLA-A2-expressing stage IV breast cancer.
Secondary
Compare the generation of human telomerase reverse transcriptase (hTERT) peptide-specific vs cytomegalovirus peptide-specific cytotoxic T-lymphocyte (CTL) immunity in patients treated with this regimen.
Correlate the dose level of this regimen with the generation of hTERT-specific CTL immunity and the development of hTERT-specific autoimmunity in these patients.
Determine the tumor response in patients treated with this regimen.
OUTLINE: This is a dose-escalation study of the telomerase: 540-548 peptide and CMV 495 peptide portions of the vaccine.
Patients receive telomerase: 540-548 peptide and CMV 495 peptide (as an immunological control) vaccine emulsified in Montanide ISA-51 subcutaneously (SC) followed by sargramostim (GM-CSF) SC on day 1 of weeks 1, 3, 5, 7, 11, 15, 19, and 27 (for a total of 8 vaccinations). Treatment continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 5-8 patients receive escalating doses of telomerase: 540-548 peptide and CMV 495 peptide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 5 or 2 of 8 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.
Patients are followed within 30 days and then at 6 and 12 months.
PROJECTED ACCRUAL: A total of 5-28 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of stage IV breast cancer
Failed at least 1 prior conventional therapy for metastatic disease
Measurable or evaluable disease by clinical, radiographic, or laboratory assessment
Measurable lesions must be at least 1 dimension
At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
The following are not considered measurable:
Pleural effusion
Bone lesions
Tumor markers
HLA-A2-expressing disease by human leukocyte antigen typing
No CNS metastases by contrast CT scan and/or MRI
No brain metastases within the past 4 years
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Not specified
Menopausal status
Not specified
Performance status
ECOG 0-1
Life expectancy
More than 6 months
Hematopoietic
WBC ≥ 3,000/mm^3
Platelet count ≥ 75,000/mm^3
Hemoglobin ≥ 10 g/dL
Hepatic
Bilirubin ≤ 1.5 times upper limit of normal (ULN)
ALT and AST ≤ 2.5 times ULN
Hepatitis B negative
Hepatitis C negative
Renal
Creatinine ≤ 1.5 times ULN
Immunologic
HIV negative
Human T-cell lymphotrophic virus-1 negative
No active infection
No major autoimmune disorder that would preclude study participation
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation
No alcohol abuse or illicit drug use within the past 12 months
No clinically significant comorbid disease or other underlying condition that would preclude study participation
No significant psychiatric disorder that would preclude giving informed consent or complying with study
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior allogeneic or autologous bone marrow or stem cell transplantation
More than 30 days since prior hematopoietic growth factors
More than 30 days since initiation of prior immunotherapy (e.g., trastuzumab [Herceptin])
Concurrent immunotherapy (e.g., trastuzumab) allowed provided regimen was initiated more than 30 days before study entry, disease is stable or progressive, and patient plans to continue immunotherapy for the duration of study participation
No other concurrent hematopoietic growth factors
Chemotherapy
More than 30 days since prior chemotherapy
No concurrent chemotherapy
Endocrine therapy
More than 30 days since prior glucocorticoids
More than 30 days since initiation of prior hormonal therapy (e.g., tamoxifen, anastrozole, or letrozole)
Concurrent hormonal therapy (e.g., tamoxifen, anastrozole, or letrozole) allowed provided regimen was initiated more than 30 days before study entry, disease is stable or progressive, and patient plans to continue hormonal therapy for the duration of study participation
No concurrent glucocorticoids
Radiotherapy
More than 30 days since prior radiotherapy
No concurrent radiotherapy
Surgery
Not specified
Other
More than 14 days since prior anticoagulants (e.g., warfarin, heparin, or enoxaparin)
Low-dose anticoagulants to maintain IV catheter patency allowed
More than 30 days since prior immunosuppressive drugs
More than 30 days since prior experimental therapy
No concurrent immunosuppressive drugs
No other concurrent investigational products
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There is 1 Location for this study
Philadelphia Pennsylvania, 19104, United States
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