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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00429572
First received: January 29, 2007
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Primary Objectives:

  1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer.
  2. To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progression free survival (PFS) rate.
  3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.

Condition Intervention Phase
Breast Cancer
Drug: Fludarabine
Drug: Melphalan
Procedure: Stem Cell Infusion
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Number of Participants With Tumor Response [ 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. ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: Transplant until death. ] [ Designated as safety issue: No ]
    Survival duration was calculated from time of transplantation by number of days.

  • Time to Progressive Disease [ Time Frame: Transplant to Progression. ] [ Designated as safety issue: No ]
    Progression-free was measured, by days, at time from transplantation to development to disease or death from any cause, which ever occurred first.

  • Grade II-IV Toxicity [ Time Frame: Up to one year. ] [ Designated as safety issue: Yes ]
    Non-hematopoietic toxicity within the first year of transplantation, acute Graft versus Host Disease (GVHD) above National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade I and chronic above Grade I are reported by participant incidence. Broad classification of adverse events (AE) categories based on anatomy and/or pathophysiology; within each category, AEs are listed accompanied by their descriptions of severity (Grade, Grade 1 least severe).

  • Number of Participants With Acute or Chronic GVHD And Response to Therapy [ Time Frame: Transplant to 1 year post transplant ] [ Designated as safety issue: No ]
    Participants diagnosed with Graft versus Host Disease (GVHD) post transplant were divided into either acute (aGVHD), normally observed within the first 100 days post-transplant; and chronic GVHD (cGVHD) cases, normally occur after 100 days, then evaluated and scored according to standard criteria from "Consensus conference on acute GVHD grading," Bone Marrow Transplant 1995; 15: 825-828, noted is type of case and whether responds to therapy.


Enrollment: 19
Study Start Date: January 1998
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allogeneic Transplantation
Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
Drug: Fludarabine
30 mg/m^2 intravenously Daily for 5 Days
Drug: Melphalan
70 mg/m^2 intravenously Daily for 2 Days
Procedure: Stem Cell Infusion
Stem Cell Infusion on Day 0.
Other Names:
  • mini-allogeneic PBPC transplantation
  • Stem Cell Transplant
  • SCT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429572

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Naoto Ueno, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00429572     History of Changes
Other Study ID Numbers: DM97-268
Study First Received: January 29, 2007
Results First Received: September 25, 2009
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
PBPC Transplantation
Stem Cell Infusion
Fludarabine
Melphalan

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Melphalan
Fludarabine
Fludarabine phosphate
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on August 26, 2014