Completed

Vaccine Plus Montanide ISA-51 and Sargramostim in Treating Patients With Stage IV Breast Cancer

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What is being tested

incomplete Freund's adjuvant

+ sargramostim
+ telomerase: 540-548 peptide vaccine
Biological
Who is being recruted

Breast Cancer

From 18 to 120 Years
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: February 2004

Summary

Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: February 5, 2020
Sourced from a government-validated database.Claim as a partner
Study start date: February 1, 2004Actual date on which the first participant was enrolled.

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. 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.

Official TitlePhase I Study Of Telomerase Peptide Vaccination For Patients With Advanced Breast Cancer 
Principal SponsorAbramson Cancer Center at Penn Medicine
Last updated: February 5, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
28 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 120 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Breast Cancer
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



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, United StatesSee the location

CompletedOne Study Center