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Home > "V" Clinical Trials Conditions > Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer  Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): University of Pennsylvania Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Combining a vaccine with Montanide ISA-51 and sargramostim may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining vaccine with Montanide ISA-51 and sargramostim in treating patients who have stage IV breast cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanDomchek, Principal Investigator, University of Pennsylvania Cancer Center
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Susan Domchek 215-615-3360
Additional Information:
Study ID Numbers: CDR0000354502; UPCC-11102
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079157
Other Stage 4 Breast Cancer Studies:
1. BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
2. Biological Therapy in Treating Women With Stage IV Breast Cancer
3. Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer
4. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
5. Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer
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