Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Advanced Breast Cancer

NCT00004174 | Completed Phase 1 DMC

• 3 other identifiers: NU 96B1NU-96B1NCI-G99-1641
• Study Type: interventional
• Target: 30
• 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. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage III or stage IV breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer

Interventions

filgrastim BIOLOGICAL

cyclophosphamide DRUG

paclitaxel DRUG

thiotepa DRUG

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: Histologically proven stage III or IV breast cancer Must have responding disease (at least 50% reduction in the sum of the products of all diameters of measurable nonbony lesions and at least symptomatic improvement in painful bone disease) following conventional dose chemotherapy Asymptomatic patients with bony disease eligible if no new lesions or other evidence of bone progression If only bone disease present, there must be no new bony lesions following cytoreductive chemotherapy Patients who are disease free following surgery (e.g., stage III patients or solitary lymph node patients following excisional biopsy) eligible No CNS disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Physiologic 60 and under Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL Hepatic: Bilirubin less than 2.5 times normal unless due to Gilbert's syndrome SGOT or SGPT less than 2.5 times normal Alkaline phosphatase less than 2.5 times normal If hepatitis C antibody positive, then liver function must be normal OR liver dysfunction must be due to metastatic disease and not chronic hepatitis Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: LVEF at least 50% unless cleared by cardiologist No myocardial infarction within the past 6 months No significant arrhythmia requiring medications No congestive heart failure Pulmonary: DLCO at least 50% predicted FEV1 and/or FVC at least 75% predicted unless due to neoplastic pulmonary involvement No serious nonneoplastic pulmonary disease (severe chronic obstructive lung disease) that would preclude study therapy Other: HIV negative Hepatitis B and C surface antigen negative No active serious medical condition that would preclude study therapy No allergy to Cremophor Not pregnant or nursing Negative pregnancy test PRIOR CONCURRENT THERAPY: No more than 3 prior treatment regimens for metastatic disease Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Prior conventional dose chemotherapy as adjuvant or as treatment for advanced disease allowed Prior doxorubicin greater than 450 mg/m2 allowed if dexrazoxane was used to reduce risk of cardiotoxicity At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to indicator lesions At least 3 weeks since other prior radiotherapy Surgery: See Disease Characteristics At least 3 weeks since prior surgery

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Cyclophosphamide; Paclitaxel; Thiotepa; Peripheral Blood Stem Cell Transplantation; Radiotherapy

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Jane N. Winter, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: April 28, 2004
• Study Start: October 1, 1999
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 10, 2013

Record last verified: 2013-07

Locations

US (1)