Sequential High-Dose Chemotherapy and Stem Cell Transplantation in Treating Patients With Chemotherapy-Sensitive Metastatic Breast Cancer

NCT00002680 | Completed Phase 2

• 3 other identifiers: CDR0000064338YALE-HIC-7372NCI-V95-0721
• Study Type: interventional
• Target: 40
• 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 kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of sequential high-dose chemotherapy followed by peripheral stem cell transplantation in treating patients with metastatic breast cancer that is responding to chemotherapy.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

filgrastim BIOLOGICAL

cyclophosphamide DRUG

megestrol acetate DRUG

melphalan DRUG

tamoxifen citrate DRUG

thiotepa DRUG

conventional surgery PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven stage IV breast carcinoma that is considered incurable by standard treatment Ongoing objective response to prior induction chemotherapy required No brain metastasis Hormone receptor status: Estrogen and progesterone receptor status known PATIENT CHARACTERISTICS: Age: Over 18 Sex: Not specified Menopausal status: Not specified Performance status: Karnofsky 90-100% Life expectancy: More than 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL Hepatic: Bilirubin less than 1.5 times upper limit of normal (unless due to benign congenital hyperbilirubinemia) PT and aPTT normal Liver biopsy normal if serologic evidence of active hepatitis B or C Renal: Creatinine no greater than 1.2 mg/dL Cardiovascular: No active heart disease LVEF at least 50% and no abnormal wall motion by MUGA scan Pulmonary: DLCO normal Other: Nutritional status adequate (more than 1,000 calories/day orally) HIV negative No other active serious medical or psychiatric disease No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix uteri Not pregnant Negative pregnancy test Fertile patients must use effective barrier contraception during and for up to 2 years after study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior mitomycin or nitrosourea No prior anthracycline greater than 500/m2 unless previously received dexrazoxane At least 4 weeks since other prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to pelvis or brain Surgery: At least 2 weeks since prior major surgery

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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Cyclophosphamide; Megestrol Acetate; Melphalan; Tamoxifen; 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; Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; 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

• Michael DiGiovanna, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 29, 2004
• Study Start: February 1, 1994
• Primary Completion: December 1, 2000
• Study Completion: December 1, 2000
• Last Updated: July 24, 2013

Record last verified: 2009-08

Locations

US (1)