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

NCT00022230 | Withdrawn Phase 1 DMC

• 2 other identifiers: CDR0000068797RWMC-0633846
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (4)

• Toxicity

• Disease-free survival

• Overall survival

• Immune functions

Interventions

aldesleukin BIOLOGICAL

filgrastim BIOLOGICAL

sargramostim BIOLOGICAL

therapeutic autologous lymphocytes BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roger Williams Medical Center: lead

Study Sites (1)

Roger Williams Medical Center

Providence, Rhode Island, 02908-4735, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

aldesleukin; Filgrastim; sargramostim; Cyclophosphamide; Doxorubicin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Lawrence G. Lum, MD, DSc

  Roger Williams Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: January 1, 2000
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

US (1)