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Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer


Phase 2
18 Years
60 Years
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer


If tumors shrink by standard-dose chemotherapy, patients will receive moderate dose
chemotherapy to prepare for the blood stem cell transplant. The drug fludarabine will be
given by vein on days 1-5. The drug melphalan will be given by vein on days 4 and 5. Day 6
will be a rest day; no drugs will be given. The blood stem cell transplant will be given on
day 7. Bone marrow from the matched donor may be used instead of blood stem cells,
particularly for unrelated donors. A catheter (tube) will be placed in a large vein in the
chest to reduce the number of times patients are stuck with a needle.

Researchers will collect blood stem cells from your brother or sister or from an unrelated
donor using granulocyte colony-stimulating factor (G-CSF) before receiving high-dose
chemotherapy. You will need to have enough stem cells before transplantation.

The drugs G-CSG, tacrolimus, and methotrexate will be given to ease side effects and help
blood counts return to normal after the transplant. G-CSF is given as a shot under the
skin, starting the day from transplant and continuing until the white blood cell count is
normal. Tacrolimus is given by vein or by mouth for 4 to 7 months; during the last month it
is given, the dose will be tapered off. Methotrexate is given by vein on days 1, 3, and 6
after transplant. Day 11 of methotrexate is given additionally if a donor is unrelated.
Blood transfusions may be needed also.

Antithymocyte globulin will be given to patients who receive blood or bone marrow from
donors whose cells do exactly match the patients or from unrelated donors.

Sometimes the transplanted cells attack the normal cells in the patient's body instead of
the cancer cells. This is called graft-vs-host disease (GVHD). The drug methylprednisolone
will be given by vein or by mouth to fight GVHD is it occurs.

Patients must stay in the hospital for about 3 to 4 weeks. Patients must stay in the
Houston area for about 100 days after the transplant. Blood tests will be done daily while
the patient is in the hospital. Blood and urine tests and chest x-rays, computer tomography
(CT) scans, and/or bone scans will be done during the 100 days.

If there are no signs of disease after 100 days, treatment will stop. Patients must return
to the clinic for check-ups once a month for the first year, 3 times a year for 4 years, and
once a year after that. If disease is till present after 100 days, but the patient does not
have GVHD, the patient may receive an infusion of donor lymphocytes by vein. This treatment
may be repeated up to 3 times with 8 weeks between infusions. If no disease is found or if
GVHD occurs, treatment will stop.

Before treatment starts, patients will have a complete exam including blood and urine tests.
An EKG (heart function test) and a heart scan will be done. Patients will have a dental
exam. A test of lung function will be done. A sample of breast tissue will be taken. This
is done with a hollow needle while the doctor looks at a CT scan or with a lighted tube
placed through a cut in the breast while the patient is under anesthesia.

Herceptin will be given every week, if you have Human Epidermal growth factor Receptor 2
(HER-2)/neu-overexpressing tumor. Prior to this an infusion heart test will be done.

This is an investigational study. Docetaxel, Melphalan, and Herceptin are approved by the
US Food and Drug Administration for use against breast cancer. About 40 patients will take
part in the study.


Inclusion Criteria:



- Recurrent or residual metastatic breast carcinoma

- Zubrod performance status less than 2

- 18-60 years old

- Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation
or unrelated HLA-compatible donor.

- No major organ dysfunction or active infection

Exclusion Criteria: None

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Tumor Response

Outcome Description:

Best response recorded from start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria of Complete Response: disappearance of all disease/symptoms > 4 weeks; Partial response, > 50% reduction in sum of products of diameters of each measurable lesion for more than 4 weeks; Stable Disease, no change in tumor size; and Progressive Disease, appearance of new lesions or > 25% increase in sum of products of diameters of any measurable lesions.

Outcome Time Frame:

Baseline to measured progressive disease (post study follow-up period 24 months starting from the date of the last drug administration). Data collected every 4 months.

Safety Issue:

No

Principal Investigator

Naoto Ueno, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

DM97-268

NCT ID:

NCT00429572

Start Date:

January 1998

Completion Date:

May 2008

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • PBPC Transplantation
  • Stem Cell Infusion
  • Fludarabine
  • Melphalan
  • Breast Neoplasms

Name

Location

U.T.M.D. Anderson Cancer Center Houston, Texas  77030