MDACC Study Summary 2006-0280

Study Summary
No. 2006-0280:.......Breast......Naoto Ueno......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2006-0280

Study Title:	Phase II study of purging of CTCs from Metastatic Breast Cancer Patients

Physician

New Patient Referral



Name:	Naoto Ueno	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Stem Cell Transplantation and Cellular Therapy	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-8754 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	As per BMT routine.

Treatment Agents:	Carboplatin Cyclophosphamide Thiotepa	Home Care:	As per BMT routine.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Patient must stay in Houston at least for 6 weeks after transplantation.


Description/ Intervention:	The goal of this clinical research study is to learn if elimination of circulating tumor cells (CTCs) in blood stem cells along with high-dose chemotherapy will help to control metastatic breast cancer. The study also will investigate the role of CTCs in breast cancer.

Study Objectives / Outcomes

Primary Objectives
1. To determine whether high-dose chemotherapy (HDCT) with purged autologous stem cell products will reduce the presence of circulating tumor cells (CTCs) among metastatic breast cancer (MBC) patients after receiving high-dose chemotherapy autologous hematopoietic stem cell transplantation.

2. To determine whether reduction of CTCs will correlate with prolonged progression-free survival (PFS).

Secondary Objectives:

1. To determine whether reduction of CTCs will correlate with prolonged overall survival (OS).

2. To characterize the biology of CTC.

Study Status Information



Study Activation / Registration Date:	02/27/2007

IRB Review and Approval Date:	09/20/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 18 to 55 years old

2) Metastatic breast carcinoma.

3) Histological confirmation of invasive breast carcinoma

4) Complete or partial response to pre-transplant standard-dose chemotherapy, or hormonal therapy. For bone disease, stable disease (SD) is allowed.

5) Patient must have tumor assessed for estrogen-receptor (ER) and progesterone-receptor (PR).

6) Persistent detectable or non-detectable CTCs by Veridex Technology after completion of standard therapy.

7) Zubrod performance status 0 or 1.

8) Patients must have adequate hematological parameters (WBC 3,000/mm3; platelet count 100,000/mm3)

9) Adequate renal funciton (serum creatinine 1.5mg/dl)

10) Adequate liver function (total bilirubin, SGPT 2 x normal).

11) Adequate cardiac function (LVEF >= 50%).

12) Adequate pulmonary function (DLCO >= 50% of predicted value).

13) Patients must sign an informed consent.

Exclusion Criteria:

1) Prior HDCT with AHST in adjuvant setting.

2) History or presence of brain/leptomeningeal metastasis.

3) History of other malignancies except cured non-melanoma skin cancer or cured cervical carcinoma in situ.

4) Presence of other severe medical illnesses or conditions.

5) Clinically significant active infections.

6) HIV infection.

7) Chronic active hepatitis.

8) Pregnant or lactating women (females of childbearing potential must use adequate contraception).

9) Medical, social or psychologic factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.

Links

Registration Number: NCT00429182
Study Information on Clinical Trials Registry (clinicaltrials.gov)