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Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer

Phase 2
18 Years
60 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Pilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer



- Determine the toxicity and tolerability of allogeneic peripheral blood stem cell
transplantation after a nonmyeloablative preparative regimen comprising anti-thymocyte
globulin, high-dose melphalan, and fludarabine in women with chemotherapy-refractory or
poor-prognosis metastatic adenocarcinoma of the breast.

- Determine the ability of this preparative regimen to facilitate long-term engraftment
of allogeneic stem cells and lymphocytes in these patients.

- Determine the response in measurable/evaluable disease and its temporal relationship to
the preparative chemotherapy used and to the onset of clinical graft-versus-host
disease (GVHD) in patients treated with this regimen.


- Determine the progression-free and overall survival of patients treated with this

- Determine the tumor response and its temporal relationship to administration of
high-dose chemotherapy and to the onset of GVHD in patients treated with this regimen.

- Determine the frequency and durability of the induction of full donor chimerism of
lymphocytes in patients treated with this regimen.

OUTLINE: This is a nonrandomized, pilot study.

- Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes
on days -8 to -4, anti-thymocyte globulin IV over 4 hours on days -7 to -4, and
high-dose melphalan IV over 30 minutes on days -3 and -2.

- Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV (and
then orally when tolerated) every 12 hours beginning on day -4 and tapered after day 42
(if no GVHD occurs) or after day 90 (if grade I acute GVHD occurs). Patients also
receive methotrexate IV on days 1, 3, and 6.

- Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo
allogeneic PBSCT on day 0. Patients also receive filgrastim (G-CSF) IV or
subcutaneously beginning on day 0 and continuing until blood counts recover.

- Donor lymphocyte infusion (DLI): Patients who show disease progression or fail to
achieve full donor type T-cell chimerism (at least 90% donor derived T-cells) by the
90-day assessment posttransplantation, and have no evidence of active GVHD may receive
DLI. Patients who have unresponsive disease with no active GVHD receive subsequent DLIs
every 6-8 weeks.

Patients are followed at 1, 3, 6, 12, 18, 24, 30, and 36 months.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the breast

- Metastatic disease

- Meets 1 of the following criteria:

- Chemotherapy-unresponsive disease defined as 1 of the following:

- Less than a partial response to 2 consecutive chemotherapy regimens that
included an anthracycline and a taxane in combination or succession

- Progression of disease during or within 3 months of completion of a taxane,
anthracycline, or platinol-based regimen

- Histologically confirmed tumor involvement on bone marrow biopsy

- Measurable or evaluable disease* defined as the following:

- Bidimensionally reproducible measurable mass by physical examination,
ultrasonography, radiography, CT scan, or MRI

- Evaluable lesions apparent on clinical exam, x-ray, CT scan, or MRI which do not
fit the criteria for measurability (e.g., ill-defined post-surgical masses or
masses assessable in 1 dimension only)

- Elevation of biological markers (e.g., CA 27.29) is considered evaluable
disease NOTE: *Bone lesions or pleural or peritoneal effusion alone are not
considered measurable or evaluable disease

- Appropriate candidate for allogeneic stem cell transplantation

- No active CNS metastases

- Available HLA-identical sibling donor

- 6/6 antigen match

- Donor CD34 cells at least 2 times 10^6/kg recipient weight

- Hormone receptor status:

- Estrogen receptor negative or positive

- Estrogen receptor positive tumors must demonstrate progression on at least
1 hormonal manipulation



- 18 to 60


- Female

Menopausal status

- Not specified

Performance status

- Karnofsky 70-100% OR

- ECOG 0-1

Life expectancy

- Not specified


- WBC at least 1,500/mm^3

- Platelet count at least 30,000/mm^3


- Bilirubin less than 3 times normal*

- AST and ALT less than 3 times normal* NOTE: *Unless abnormality due to malignancy


- Creatinine no greater than 1.6 mg/dL


- LVEF greater than 40% by echocardiography or MUGA

- No myocardial infarction within the past 6 months


- DLCO greater than 40% of predicted


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No serious localized or systemic infection

- No hypersensitivity to E. coli-derived products

- No history of non-breast malignant disease within the past 5 years except completely
excised nonmelanoma skin cancer or carcinoma in situ of the cervix

- No chronic inflammatory disorder requiring concurrent glucocorticosteroids or other
immunosuppressive medication

- No psychological condition or social situation that would preclude study


Biologic therapy

- Not specified


- See Disease Characteristics

Endocrine therapy

- No concurrent glucocorticoids


- No prior radiotherapy to an indicator lesion unless the lesion shows evidence of
progression after discontinuation of the therapy


- Not specified


- No concurrent immunosuppressive medication

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

Edward D. Ball, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Rebecca and John Moores UCSD Cancer Center La Jolla, California  92093-0658