Know Cancer

or
forgot password

Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Vaccination Of High Risk Breast Cancer Patients With Heptavalent Antigen - Keyhole Limpet Hemocyanin Conjugate Plus The Immunological Adjuvant QS21


OBJECTIVES:

- Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y,
TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet
hemocyanin plus QS21 induces an antibody response against these individual antigens and
breast cancer cells expressing these antigens in patients at high risk for breast
cancer recurrence.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: 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.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine whether immunization with multiple antigens comprising GM2, Globo-H, Lewis y, TF(c), sTn(c), Tn(c), and glycosylated MUC-1 32(aa) conjugated to keyhole limpet hemocyanin plus QS21 induces an antibody response

Outcome Description:

against these individual antigens and breast cancer cells expressing these antigens in patients at high risk for breast cancer recurrence.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Teresa Ann Gilewski, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

01-019

NCT ID:

NCT00030823

Start Date:

March 2001

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021