Status:
COMPLETED
Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief 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 cel...
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00079157
Start Date
February 1 2004
End Date
December 1 2007
Last Update
February 5 2020
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283