Vaccine Therapy and QS21 in Treating Patients With Metastatic Breast Cancer

NCT00470574 | Completed Results

• 3 other identifiers: 06-156P30CA008748MSKCC-06156
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with QS21 may cause a stronger immune response and kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and how well giving vaccine therapy together with QS21 works in treating patients with metastatic breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (2)

• Safety

  2 years

• Immune Response

  2 years

Secondary Outcomes (1)

• Presence of Circulating Tumor Cells

  2 years

Study Arms (1)

Vaccine Therapy and QS21

EXPERIMENTAL

Patients receive sialyl Lewisª -keyhole limpet hemocyanin conjugate vaccine subcutaneously (SC) and QS21 immunoadjuvant SC once in weeks 1, 2, 3, 7, and 19 in the absence of disease progression or unacceptable disease. Blood samples are collected periodically and evaluated for circulating tumor cells and reactivity against sialyl Lewisª antigen in ELISA and/or immunoprecipitation-western blot assays. After completion of study treatment, patients are followed every 3 months

Biological: QS21; Biological: sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine; Other: immunoenzyme technique; Other: immunologic technique; Other: laboratory biomarker analysis

Interventions

QS21 BIOLOGICAL

Vaccine Therapy and QS21

sialyl Lewisª-keyhole limpet hemocyanin conjugate vaccine BIOLOGICAL

Vaccine Therapy and QS21

immunoenzyme technique OTHER

Vaccine Therapy and QS21

immunologic technique OTHER

Vaccine Therapy and QS21

laboratory biomarker analysis OTHER

Vaccine Therapy and QS21

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed stage IV breast cancer meeting 1 of the following criteria: * No evidence of disease * Stable disease on hormonal therapy * Stable disease must be present for ≥ 2 months and include \< 30% decrease or \< 20% increase in the sum of the longest diameter of target lesion * No new target lesions or unequivocal progression of non-target lesions * Elevation in the CA 153 (BR2729) or CEA values allowed * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female or male * Menopausal status not specified * Karnofsky performance status 80-100% * Lymphocyte count ≥ 500/mm³ * WBC ≥ 3,000/mm³ * Creatinine ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 1.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of allergy to seafood * No NYHA class III-IV cardiac disease * No other active cancers except basal cell or squamous cell carcinoma of the skin * No active infection requiring antibiotic treatment * No known history of immunodeficiency or autoimmune disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * At least 4 weeks since prior radiotherapy * At least 4 weeks since prior surgery * At least 6 weeks since prior immunotherapy * No prior sialyl Lewisª antigen * No concurrent immunosuppressive medications (i.e., corticosteroids) * Concurrent hormonal therapy allowed

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

saponin QA-21V1; Immunoenzyme Techniques; Immunologic Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoassay; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques

Results Point of Contact

• Title: Teresa Gilewski, MD
• Organization: Memorial Sloan Kettering Cancer Center

gilewskt@mskcc.org

(212) 639-2000

Study Officials

• Teresa Ann Gilewski, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: March 20, 2007
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: November 18, 2020
• Results First Posted: November 16, 2020

Record last verified: 2020-11

Locations

US (1)