Vaccine Therapy in Treating Patients at High Risk for Breast Cancer Recurrence

NCT00030823 | Completed Results

• 3 other identifiers: 01-019MSKCC-01019NCI-H01-0084
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer. PURPOSE: Pilot trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Safety

  By assessing the toxicity and will be graded following immunization with polyvalent vaccine in accordance with the NCI Common Toxicity Criteria 2.0.

  2 years

Study Arms (1)

Vaccine

EXPERIMENTAL

Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.

Biological: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine; Biological: QS21

Interventions

Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine BIOLOGICAL

Vaccine

QS21 BIOLOGICAL

Vaccine

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of breast cancer at high risk for recurrence, defined by one of the following: * Stage IV that is free of all known disease after eradication by surgery, radiotherapy, or chemotherapy * May or may not have elevated CA 15-3 or CEA levels * Stage I, II, or III previously treated with adjuvant chemotherapy and clinically free of identifiable disease, but have rising CA 15-3 or CEA levels * Rising CA 15-3 and CEA defined as a prior normal level increased on 2 consecutive occasions at least 2 weeks apart * For patients with a significant history of smoking who have a chronically elevated CEA (less than 15), CEA must be increased at least 1.5 times the uppermost chronic value on 2 consecutive occasions at least 2 weeks apart * Stage III and completed adjuvant therapy no more than 24 months ago * Recurrence in the ipsilateral axilla after lumpectomy and/or axillary dissection or modified radical mastectomy * Recurrence in the ipsilateral breast after lumpectomy and/or axillary dissection * Stage II with at least 4 positive axillary nodes and completed adjuvant therapy no more than 24 months ago * Stage IV that is stable on hormonal therapy * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Male or female Menopausal status: * Not specified Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Lymphocyte count at least 500/mm\^3 * WBC at least 3,000/mm\^3 Hepatic: * AST no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No clinically significant New York Heart Association class III or IV cardiac disease Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No prior seafood allergy * No known prior immunodeficiency or autoimmune disease * No other active cancer except basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 weeks since prior immunotherapy * No prior vaccine with any of the antigens in this study Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No concurrent chemotherapy Endocrine therapy: * See Disease Characteristics Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * See Disease Characteristics * At least 4 weeks since prior surgery * Concurrent surgery for local recurrence allowed if patient remains disease free

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 Publications (1)

• Armstrong JL, Ragupathi G, Powell S, et al.: Preliminary data of vaccination of high risk breast cancer (BC) patients (pts) with a heptavalent antigen: keyhole limpet hemocyanin (KLH) conjugate plus the immunologic adjuvant QS-21. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-675, 2003.

  RESULT

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

saponin QA-21V1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Teresa Gilewski
• Organization: Memorial Sloan Kettering Cancer Center

gilewskt@mskcc.org

646-888-4557

Study Officials

• Teresa Ann Gilewski, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

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: February 14, 2002
• First Posted: January 27, 2003
• Study Start: March 1, 2001
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: December 30, 2015
• Results First Posted: December 30, 2015

Record last verified: 2015-11

Locations

US (1)