NCT00008203

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Biological therapy may interfere with the growth of the cancer cells. It is not yet known which post-transplant biological therapy regimen is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of cyclosporine and interferon gamma to that of interleukin-2 following combination chemotherapy and bone marrow or peripheral stem cell transplantation in women who have stage II or stage III breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started May 1996

Longer than P75 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1996

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2001

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

June 5, 2003

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

February 4, 2013

Status Verified

May 1, 2003

Enrollment Period

9.6 years

First QC Date

January 6, 2001

Last Update Submit

February 1, 2013

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IIIA breast cancerstage IIIB breast cancer

Interventions

aldesleukinBIOLOGICAL
recombinant interferon gammaBIOLOGICAL
carboplatinDRUG
cyclophosphamideDRUG
cyclosporineDRUG
thiotepaDRUG
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Stage II with at least 10 lymph nodes involved with malignancy OR * Stage III (any T3b-T4, N2 or N3, M0) * Ineligible for other high priority national or institutional study * No metastasis to brain (confirmed by CT or MRI) * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to physiologic 65 Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2 times normal Renal: * Creatinine less than 1.5 times normal Cardiovascular: * LVEF at least 45% Other: * HIV negative * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 3 cycles of prior chemotherapy required * Stage II patients must have completed 4-6 courses of doxorubicin and/or taxol-based adjuvant chemotherapy * Stage III patients must have achieved complete or partial response to 4-6 courses of doxorubicin and/or taxol-based induction chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Not specified 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 (1)

Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • Vahdat LT, Cohen DJ, Zipin D, Lo KS, Donovan D, Savage D, Tiersten A, Nichols G, Troxel A, Hesdorffer CS. Randomized trial of low-dose interleukin-2 vs cyclosporine A and interferon-gamma after high-dose chemotherapy with peripheral blood progenitor support in women with high-risk primary breast cancer. Bone Marrow Transplant. 2007 Aug;40(3):267-72. doi: 10.1038/sj.bmt.1705692. Epub 2007 Jun 11.

    PMID: 17563739RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

aldesleukinInterferon-gammaCarboplatinCyclophosphamideCyclosporineThiotepaPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsCyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Charles S. Hesdorffer, MD

    Herbert Irving Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 6, 2001

First Posted

June 5, 2003

Study Start

May 1, 1996

Primary Completion

December 1, 2005

Study Completion

May 1, 2008

Last Updated

February 4, 2013

Record last verified: 2003-05

Locations

US(1)