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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00079157 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Biological: incomplete Freund's adjuvant Biological: sargramostim Biological: telomerase: 540-548 peptide vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Study Of Telomerase Peptide Vaccination For Patients With Advanced Breast Cancer |
Estimated Enrollment: | 28 |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Measurable or evaluable disease by clinical, radiographic, or laboratory assessment
Measurable lesions must be at least 1 dimension
The following are not considered measurable:
No CNS metastases by contrast CT scan and/or MRI
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 14 days since prior anticoagulants (e.g., warfarin, heparin, or enoxaparin)
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4283 | |
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 |
Principal Investigator: | Susan Domchek, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000354502, UPCC-11102 |
Study First Received: | March 8, 2004 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00079157 History of Changes |
Health Authority: | Unspecified |
recurrent breast cancer stage IV breast cancer |
Immunologic Factors Skin Diseases Adjuvants, Immunologic Breast Neoplasms |
Freund's Adjuvant Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Immunologic Factors Skin Diseases Physiological Effects of Drugs |
Adjuvants, Immunologic Breast Neoplasms Freund's Adjuvant Pharmacologic Actions Breast Diseases |