MDACC Study Summary 2006-0349

Study Summary
No. 2006-0349:.......Breast......Naoto Ueno......Stem Cell Transplantation and Cellular Therapy

Study Summary Title



Study Summary Number:	2006-0349

Study Title:	Phase 2 Study of 153 Sm-EDTMP Followed by Autologous Peripheral Blood Stem Cell Transplantation for Breast Cancer Patients with Bone Only Metastases

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:	Per BMT standard care. At least 2 times/week for the first two months.

Treatment Agents:	Samarium 153-EDTMP	Home Care:	None

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Per BMT standard care. In general, 2-3 weeks.


Description/ Intervention:	The goal of this clinical research study is to see if treatment with radiation from 153 Sm-EDTMP and a stem cell transplant will control breast cancer that has spread to the bone. The side effects of the study drug will also be studied.

Study Objectives / Outcomes

Primary objectives

To determine the time to progression in subjects with breast cancer metastatic to bone only treated with ¹⁵³Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT).

Secondary objectives

To determine the overall survival at one year.
To determine the efficacy of ¹⁵³Sm-EDTMP at 6 months.
To assess pain in subjects treated with ¹⁵³Sm-EDTMP.
To determine the safety of ¹⁵³Sm-EDTMP.

Study Status Information



Study Activation / Registration Date:	03/07/2007

IRB Review and Approval Date:	10/27/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

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) Stage IV breast cancer metastatic to bone and/or bone marrow only.

2) Age between 18 and 65 years.

3) ECOG performance score of 0, 1

4) Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.

5) Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.

6) WBC >/= 3.5 x10^9/L, Hb >/= 10 g/dL, platelets >/= 100 x10^9/L.

7) Adequate pulmonary function defined as FEV1, FVC and DLCO (corrected for hemoglobin) >/= 50% of predicted.

8) Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of >/= 45%.

9) Serum total bilirubin < 2x ULN, and ALT/SGPT < 3x ULN

10) Creatinine clearance of >/= 75 mL/min for subjects up to 50 years of age, and adjusted for age by a 10% decrease per decade for subjects of more than 50 years of age.

11) Ability to understand the study and provide informed consent.

Exclusion Criteria:

1) Any metastatic disease or history of metastatic disease other than skeletal metastases

2) Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.

3) Previous strontium-89 or samarium-153 treatment for any skeletal involvement.

4) Cumulative external beam radiation to > 20% of marrow volume or > 40 Gy to any single region of the spinal cord.

5) Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.

6) Life expectancy severely limited by concomitant illness (less than 6 months).

7) Prior nephrectomy.

8) History of hemorrhagic cystitis obstructive uropathy or hydronephrosis.

9) Uncontrolled arrhythmia or symptomatic cardiac disease.

10) Current gross hematuria in UA in the absence of vaginal bleeding.

11) Evidence of HIV-seropositivity.

12) Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.

13) Use of any investigational agent within 30 days preceding enrollment.

14) Pregnant or lactating women.

15) Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.

16) Myelodysplastic syndrome.

17) Subject weight of more than 125 kg.

Links

Registration Number: NCT00429507
Study Information on Clinical Trials Registry (clinicaltrials.gov)