Suspended

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

anti-thymocyte globulin

+ filgrastim

+ graft-versus-tumor induction therapy

BiologicalDrugProcedure
Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

From 18 to 60 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 2003
See protocol details

Summary

Principal SponsorUniversity of California, San Diego
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2003

Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * 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. Secondary * Determine the progression-free and overall survival of patients treated with this regimen. * 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.

Official TitlePilot Study Of Allogeneic Peripheral Blood Progenitor Cell Transplantation In Patients With Chemotherapy-Refractory Or Poor-Prognosis Metastatic Breast Cancer 
NCT00074269
Principal SponsorUniversity of California, San Diego
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

5 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

Criteria

DISEASE CHARACTERISTICS: * 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 PATIENT CHARACTERISTICS: Age * 18 to 60 Sex * Female Menopausal status * Not specified Performance status * Karnofsky 70-100% OR * ECOG 0-1 Life expectancy * Not specified Hematopoietic * WBC at least 1,500/mm\^3 * Platelet count at least 30,000/mm\^3 Hepatic * Bilirubin less than 3 times normal\* * AST and ALT less than 3 times normal\* NOTE: \*Unless abnormality due to malignancy Renal * Creatinine no greater than 1.6 mg/dL Cardiovascular * LVEF greater than 40% by echocardiography or MUGA * No myocardial infarction within the past 6 months Pulmonary * DLCO greater than 40% of predicted Other * 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 participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * No concurrent glucocorticoids Radiotherapy * No prior radiotherapy to an indicator lesion unless the lesion shows evidence of progression after discontinuation of the therapy Surgery * Not specified Other * No concurrent immunosuppressive medication

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Rebecca and John Moores UCSD Cancer Center

La Jolla, United StatesSee the location
SuspendedOne Study Center