NCT00301730

Brief Summary

RATIONALE: Biological therapy, such as cellular adoptive immunotherapy, may stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying how well cellular adoptive immunotherapy works in treating a patient who has undergone a donor stem cell transplant for breast cancer that has spread to the lung.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_1 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

October 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2006

First QC Date

March 9, 2006

Last Update Submit

April 27, 2015

Conditions

Breast CancerMetastatic Cancer

Keywords

lung metastasesstage IV breast cancerrecurrent breast cancer

Interventions

aldesleukinBIOLOGICAL
therapeutic tumor infiltrating lymphocytesBIOLOGICAL
trastuzumabBIOLOGICAL
paclitaxelDRUG
conventional surgeryPROCEDURE

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of stage IIB HER2/neu-expressing breast cancer 6½ years ago * Received a T-cell-depleted allogeneic stem cell transplantation (SCT) from a 6/6 HLA-matched sibling donor for refractory metastatic breast cancer * Developed pulmonary metastases during adjuvant chemotherapy following modified radical mastectomy * Pulmonary metastases progressed after prior allogeneic SCT * Responded in an objective and measurable manner to prior allogeneic lymphocyte infusion, post-transplantation chemotherapy, and trastuzumab (Herceptin®) * Disease limited to the thoracic cavity * Operable tumor with at least 1 cm of surgically accessible lesion * Preoperative risk assessment indicating ≤ 5% risk of mortality and \< 15% risk of significant morbidity for pulmonary metastasectomy * Enrolled on protocol CC# 00-C-0119 * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * ECOG performance status 0-2 * Life expectancy \> 6 months * Negative pregnancy test * Adequate pulmonary reserve * Prior graft-versus-host disease (GVHD) ≤ grade 1 * No concurrent GVHD * No active infection nonresponsive to antimicrobial therapy * No active psychiatric disorder that would preclude study compliance PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior systemic immunosuppressive therapy * At least 2 weeks since prior cytotoxic therapy and immunotherapy (e.g. trastuzumab \[Herceptin®\]) * No concurrent immunosuppressive therapy

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

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

aldesleukinTrastuzumabPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Michael R. Bishop, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 13, 2006

Study Start

October 1, 2005

Last Updated

April 28, 2015

Record last verified: 2006-04

Locations

US(1)