Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer

• Status: Withdrawn
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies use different ways to stimulate the immune system and stop tumor cells from growing. Combining chemotherapy with biological therapy may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects of giving chemotherapy together with biological therapy and to see how well they work in treating patients with stage II or stage III breast cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roger Williams Medical Center
• Treatments: Aldesleukin; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Sargramostim

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II or III adenocarcinoma of the breast

• High-risk disease

• At least 4 positive lymph nodes

• Fewer than 4 positive lymph nodes considered high-risk if one of the following is present:

• HER2/neu-positive disease

• Enlarged axillary nodes

• Extra capsular extension of tumor from lymph node

• Dermal lymphatic invasion

• Vascular invasion

• Bilateral disease

• Familial breast cancer

• T4 locally advanced disease

• Clinically chemosensitive to prior paclitaxel (or other taxane), doxorubicin, and cyclophosphamide

• No relapse after chemotherapy

• No clinical evidence of brain metastases

• Hormone receptor status:

• Estrogen and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 70-100% OR

• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Granulocyte count at least 1,500/mm^3

• Platelet count at least 50,000/mm^3

• Hemoglobin greater than 8 g/dL

Hepatic:

• Bilirubin less than 1.5 times normal

• SGOT less than 1.5 times normal

Renal

• Creatinine less than 1.8 mg/dL

• Creatinine clearance at least 60 mL/min

• BUN less than 1.5 times normal

Cardiovascular:

• Ejection fraction at least 45% by MUGA

• No uncontrolled or significant cardiovascular disease

• No myocardial infarction within the past year

• No significant congestive heart failure

Pulmonary:

• FEV_1 at least 60% predicted

• DLCO at least 60% predicted

• FVC at least 60% predicted

Other:

• No other malignancy except curatively treated squamous cell carcinoma in situ of the cervix or basal cell skin cancer

• No other serious medical or psychiatric illness that would preclude study participation

• HIV negative

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• Prior standard chemotherapy with anthracyclines or combination chemotherapy involving a combination of taxanes, doxorubicin, and/or cyclophosphamide allowed

Endocrine therapy:

• No concurrent hormonal therapy for breast cancer

• Concurrent hormonal therapy for nondisease-related conditions (e.g., insulin for diabetes) allowed

• Concurrent steroids for adrenal failure, septic shock, or pulmonary toxicity allowed

Radiotherapy:

• Not specified

Surgery:

• Prior complete resection of tumor allowed

Other:

• Prior successful neoadjuvant therapy allowed