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


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Vaccine-Preventable Diseases and Specific Vaccines


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

This study has been suspended.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Vaccines may make the body build an immune response and decrease the recurrence of breast cancer.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who are at high risk for breast cancer recurrence.

Condition Treatment or Intervention Phase
Breast Cancer
Male Breast Cancer
 Drug: Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine
 Drug: QS21
 Procedure: biological response modifier therapy
 Procedure: non-specific immune-modulator therapy
 Procedure: non-tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase I

MedlinePlus related topics:  Breast Cancer;   Male Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Pilot Study of Vaccination With a Heptavalent Antigen-Keyhole Limpet Hemocyanin Conjugate Plus QS21 in Patients at High Risk for Breast Cancer Recurrence

Further Study Details: 

OBJECTIVES:

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.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Location Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Teresa Ann Gilewski, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000069200; MSKCC-01019; NCI-H01-0084
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  February 14, 2002
ClinicalTrials.gov Identifier:  NCT00030823
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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August 22, 2008



Page Updated: November 22, 2004
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