NCT00020176

Brief Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

June 20, 2013

Status Verified

November 1, 2004

First QC Date

July 11, 2001

Last Update Submit

June 18, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancermale breast cancer

Interventions

filgrastimBIOLOGICAL
therapeutic allogeneic lymphocytesBIOLOGICAL
cyclophosphamideDRUG
cyclosporineDRUG
fludarabine phosphateDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Stage IV breast cancer * Measurable disease * Progressive disease * Increase in disease mass or less than partial response to therapy * At least one prior chemotherapy regimen for metastatic disease and progressed * Must have received prior therapy with a taxane and an anthracycline * Estrogen/progesterone receptor-positive patients must have received and progressed on at least one hormonal agent in adjuvant or metastatic setting * Her2-neu-expressing patients must have received and progressed on trastuzumab (Herceptin®) in adjuvant or metastatic setting * Prior autologous stem cell transplantation allowed if less than complete response or disease progression in adjuvant or metastatic setting * Consenting first-degree relative with at least 5 out of 6 HLA-antigen match (may include mismatch at the D locus) * Hormone receptor status: * Estrogen receptor status known * Progesterone receptor status known PATIENT CHARACTERISTICS: Age: * 18 to 70 Sex: * Male or female Menopausal status: * Not specified Performance status: * Karnofsky 80-100% Life expectancy: * More than 6 months Hematopoietic: * Not specified Hepatic: * Bilirubin ≤ 2 mg/dL * SGOT \< 4 times upper limit of normal * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal: * Creatinine ≤ 1.5 mg/dL * Creatinine clearance ≥ 50 mL/min Cardiovascular: * Left ventricular ejection fraction \> 45% Pulmonary: * DLCO ≥ 50% of predicted Other: * HIV negative * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * Recovered from prior stem cell transplantation Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease Characteristics * No concurrent steroids Radiotherapy: * Not specified Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

NCI - Center for Cancer Research

Bethesda, Maryland, 20892, United States

Location

Related Publications (6)

  • Bishop MR. Nonmyeloablative allogeneic hematopoietic stem cell transplantation for metastatic breast cancer. Clin Breast Cancer. 2003 Apr;4(1):39-45. doi: 10.3816/cbc.2003.n.010.

    PMID: 12744757BACKGROUND

  • Bishop MR, Fowler DH, Marchigiani D, Castro K, Kasten-Sportes C, Steinberg SM, Gea-Banacloche JC, Dean R, Chow CK, Carter C, Read EJ, Leitman S, Gress R. Allogeneic lymphocytes induce tumor regression of advanced metastatic breast cancer. J Clin Oncol. 2004 Oct 1;22(19):3886-92. doi: 10.1200/JCO.2004.01.127. Epub 2004 Aug 16.

    PMID: 15314059RESULT

  • Bishop MR, Steinberg SM, Gress RE, Hardy NM, Marchigiani D, Kasten-Sportes C, Dean R, Pavletic SZ, Gea-Banacloche J, Castro K, Hakim F, Krumlauf M, Read EJ, Carter C, Leitman SF, Fowler DH. Targeted pretransplant host lymphocyte depletion prior to T-cell depleted reduced-intensity allogeneic stem cell transplantation. Br J Haematol. 2004 Sep;126(6):837-43. doi: 10.1111/j.1365-2141.2004.05133.x.

    PMID: 15352988RESULT

  • Bishop MR, Kasten-Sportes C, Dean R, et al.: Preemptive DLI after T cell-depleted reduced-intensity allogeneic HSCT for metastatic breast cancer: effect on engraftment, GVHD, and anti-tumor response. [Abstract] Blood 102 (11): A- 5567, 2003.

    RESULT

  • Bishop MR, Marchigiani D, Grasmeder S, et al.: Demonstration of clinical responses to adoptive cellular therapy using allogeneic T cells in metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-657, 2003.

    RESULT

  • Bishop MR, Marchigiani D, Odom J, et al.: Contribution of T cells to engraftment: a comparison of T cell depleted vs. T cell replete allografts after reduced-intensity conditioning. [Abstract] Blood 102 (11): A-2447, 2003.

    RESULT

MeSH Terms

Conditions

Breast NeoplasmsBreast Neoplasms, Male

Interventions

FilgrastimCyclophosphamideCyclosporinefludarabine phosphatePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Michael R. Bishop, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

June 1, 2000

Study Completion

August 1, 2007

Last Updated

June 20, 2013

Record last verified: 2004-11

Locations

US(2)