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Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer

NCT00376805 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-12-28

Study results available
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Summary

RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's cells. Giving NK cells from a related donor may kill the tumor cells.

PURPOSE: This study furthers the research of previous studies (MT2003-01 and MT2004-25) which were to determine a specific preparatory regimen (cyclophosphamide and fludarabine) could create an environment in which infused NK cells can grow and effectively treat patients with relapsed AML. This study will test the previous regimen in patients with breast cancer.

Conditions

Interventions

DRUG

Fludarabine

administered intravenously 25 mg/m\^2 times 5 doses

DRUG

Cyclophosphamide

administered intravenously 60 mg/kg days times 2 doses.

RADIATION

Total body irradiation

200 cGy (gray) on day -1

OTHER

Natural killer cell infusion

Infused cell dose is within the range of 1.5-8.0 x 10\^7/kg. Cell counts are based on total cells infused after the activation culture and washing determined on the morning of infusion.

BIOLOGICAL

Interleukin-2

administered subcutaneously (10 MU) 3 times per week for 6 doses

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Jeffrey Miller, MD · Masonic Cancer Center, University of Minnesota

  • Sarah Cooley, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-09-30
Completion
2010-01-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00376805 on ClinicalTrials.gov