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

NCT00079157 | Completed Phase 1

• 2 other identifiers: CDR0000354502UPCC-11102
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Interventions

incomplete Freund's adjuvant BIOLOGICAL

sargramostim BIOLOGICAL

telomerase: 540-548 peptide vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

incomplete Freund's adjuvant; sargramostim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Susan Domchek, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 10, 2004
• Study Start: February 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

US (1)