- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00079157
Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
Phase I Study Of Telomerase Peptide Vaccination For Patients With Advanced Breast Cancer
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104-4283
- Abramson Cancer Center of the University of Pennsylvania
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Susan Domchek, MD, Abramson Cancer Center of the University of Pennsylvania
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000354502
- UPCC-11102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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