Breast Cancer Clinical Trial
Official title:
Combination of Chemotherapy With Taxol, Adriamycin, and Cytoxan (TAC), Multiple Infusions of Activated T Cells (ATC), Interleukin-2 (IL-2) and GM-CSF for High Risk Breast Cancer With and Without Her2/Neu Overexpression. (Phase I/II)
Verified date | May 2015 |
Source | Roger Williams Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2007 |
Est. primary completion date | January 2007 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Roger Williams Medical Center | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Roger Williams Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Toxicity | Yes | ||
Primary | Disease-free survival | No | ||
Primary | Overall survival | No | ||
Primary | Immune functions | No |
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