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N/A N=14 Treatment

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

Breast Cancer

Enrolled (actual)
14
Serious AEs
7.7%
Results posted
Dec 2015
Primary outcome: Primary: Safety — 13 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine (Biological); QS21 (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Memorial Sloan Kettering Cancer Center
Primary completion
Feb 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Safety
13

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00030823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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