Completed

Randomized Phase III Trial of G-CSF Primed Autologous Bone Marrow Versus Peripheral Blood Progenitor Cells (PBPC) as Hematopoietic Support for High-Dose Cyclophosphamide, Thiotepa, and Carboplatin (CTCb) Therapy in Poor Prognosis Breast Cancer

What is being tested

peripheral blood stem cell transplantation

+ autologous bone marrow transplantation

Procedure

Who is being recruted

Breast Diseases+3

+ Neoplasms

+ Neoplasms by Site

From 18 to 60 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: June 1996

See protocol details

Summary

Principal SponsorWake Forest University Health Sciences

Last updated: August 10, 2018

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 1996

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Compare engraftment rates using G-CSF primed autologous bone marrow vs PBCP as hematopoietic support following high dose CTCb for patients with poor prognosis breast cancer. II. Compare the complications of these two methods of hematopoietic progenitor cell collections. III. Compare Stage IV patients with bone or bone marrow involvement (assigned to PBPC collections) with Stage IV patients randomized to PBPC collections relative to the number of leukaphereses needed to collect the required number of progenitor cells as well as assess engraftment rates between these two groups. IV. Assess the response to high dose CTCb in this group of patients. OUTLINE: All patients will receive G-CSF priming therapy for 5 consecutive days. Patients will then be randomized into two treatment arms: Arm 1 consists of autologous PBPC collection Arm 2 consists of autologous bone marrow collection Within 2 weeks after progenitor cell collection, all patients will receive high dose CTCb therapy by continuous infusion for 5 days, followed by autologous hematopoietic progenitor cell infusion at least three days later. G-CSF will also be given after infusion until ANC count is over 5,000 or over 1,000 for 3 consecutive days. PROJECTED ACCRUAL: 66 patients will be accrued at a rate of 24 per year.

NCT00002942

Principal SponsorWake Forest University Health Sciences

Last updated: August 10, 2018

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

136 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed Stage IIIB and IV adenocarcinoma of the breast Stage II-IIIA adenocarcinoma of the breast with poor risk features (including poorly differentiated histology, high mitotic rate, hormone receptor negative, high S phase) with at least three involved axillary lymph nodes, estimated five year relapse free survival rate less than 50%, and does not qualify for higher priority protocol treatments No central nervous system involvement PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life expectancy: Greater than 2 months Hematopoietic: Platelet count greater than 75,000/mm3 Neutrophils greater than 1500/mm3 Hepatic: Serum bilirubin, alkaline phosphatase, and SGOT or SGPT less than 3 times upper limit of normal, unless due to disease Renal: Serum creatinine less than 1.5 times upper limit of normal Creatinine clearance at least 60 mL.min Cardiovascular: Ventricular ejection fraction at least 45% No uncontrolled or severe cardiovascular disease, including recent myocardial infarction, congestive heart failure, angina, life threatening arrhythmia, or hypertension Pulmonary: DLCO and spirometry at least 50% of predicted Other: Not HIV positive Not HBsAG positive Not pregnant Must have functioning central venous catheter No active infection No uncontrolled diabetes mellitus No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: No prior hematopoietic progenitor cell support Chemotherapy: No prior dose intensive therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, United StatesOpen Comprehensive Cancer Center of Wake Forest University Baptist Medical Center in Google Maps

CompletedOne Study Center