S0348 Vaccine Therapy in Treating Patients With Stage IIIB or Stage IV Breast Cancer in Remission

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB or stage IV breast cancer in remission.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Vaccines

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed breast cancer

• Stage IIIB-IV disease

• Patients with stage IV disease must have metastasis to the bone only AND documentation of negative or improved bone scan showing evidence of recalcification by plain film x-ray OR MRI showing normalization of marrow signal

• In remission (no evidence of disease)

• Must have completed appropriate treatment (e.g., radiotherapy and chemotherapy) for primary disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Not specified

Menopausal status

• Not specified

Performance status

• Zubrod 0-2

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• No known history of hepatitis B or C

Renal

• Not specified

Immunologic

• No known HIV positivity

• No known history of immune-deficiency disorder

• No history of allergic reaction to prior vaccinia vaccinations

• No autoimmune disease requiring concurrent treatment

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Concurrent trastuzumab (Herceptin®) allowed provided it is not part of treatment on another clinical trial

Chemotherapy

• See Disease Characteristics

• At least 28 days since prior cytotoxic chemotherapy

Endocrine therapy

• At least 28 days since prior steroid therapy

• Concurrent hormonal therapy allowed provided it is not part of treatment on another clinical trial

Radiotherapy

• See Disease Characteristics

• At least 28 days since prior radiotherapy

Surgery

• Not specified

Other

• At least 28 days since prior and no concurrent treatment on another clinical trial

• Patients enrolled in a SWOG phase III metastatic trial (e.g.,SWOG-S0226 or SWOG-S0347) who have achieved complete remission but not yet progressed are not eligible

• Patients enrolled in a SWOG phase II metastatic trial or phase II/III adjuvant or neoadjuvant trial (e.g., SWOG-S0012, SWOG-S0215, SWOG-S0221, SWOG-S0338, or SWOG-S0430) who have achieved complete remission/no evidence of disease status and are no longer receiving study treatment are eligible

• Concurrent bisphosphonates allowed provided it is not part of treatment on another clinical trial