- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00376805
Allogeneic Natural Killer (NK) Cells in Patients With Advanced Metastatic Breast Cancer
Allogeneic Natural Killer Cells in Patients With Advanced Metastatic Breast Cancer
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- Masonic Cancer Center at University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Diagnosis of metastatic breast cancer that has progressed on or failed at least one salvage chemotherapy regimen for metastatic disease and that meets the following disease specific related criteria:
- Measureable metastatic disease per Response Evaluation Criteria In Solid Tumor (RECIST) - bone only not eligible.
- Disease progression while receiving prior therapy with a hormonal agent (if estrogen/progesterone receptor-positive) and/or trastuzumab (Herceptin®) (if HER2-neu positive)
- Brain metastases allowed provided they are stable for ≥ 3 months after prior treatment
- Related HLA-haploidentical natural killer cell donor available (by ≥ class I serologic typing)
- Male or female
- Performance status 50-100%
- Platelet count ≥ 80,000/mm³ (unsupported by transfusions)
- Hemoglobin ≥ 9 g/dL (unsupported by transfusions)
- Absolute neutrophil count ≥ 1,000/mm³ (unsupported by sargramostim [GM-CSF] or filgrastim [G-CSF])
- Creatinine ≤ 2.0 mg/dL
- Liver function tests < 5 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF > 40%*
- Pulmonary function > 50%* (DLCO corrected AND FEV_1)
- No active infection (i.e., afebrile, off antibiotics, and no uninvestigated radiologic lesions)
Exclusion Criteria:
- At least 3 days since prior prednisone or other immunosuppressive medications
- No other concurrent therapy for cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All Treated Patients
All patients with advanced metastatic breast cancer treated with natural killer cells after receiving fludarabine, cyclosphosphamide and total body irradiation.
|
administered intravenously 25 mg/m^2 times 5 doses
Other Names:
administered intravenously 60 mg/kg days times 2 doses.
Other Names:
200 cGy (gray) on day -1
Other Names:
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.
Other Names:
administered subcutaneously (10 MU) 3 times per week for 6 doses
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients Who Had Expansion of Natural Killer Cells
Time Frame: Day 14
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Successful Natural Killer (NK) cell expansion is defined as detection of an absolute circulating donor-derived NK cell count of >100 cells/ul of whole blood 14 days after infusion with <5% donor T and B cells in mononuclear population (in metastatic breast cancer patients).
|
Day 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Patients by Disease Response
Time Frame: 6 Months, 1 Year
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Defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria:
of clinical benefit (CB; stable disease for greater than 6 months. |
6 Months, 1 Year
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Number of Patients Who Died While on Study
Time Frame: Within 100 days, After 100 days
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Number of patients who died within 100 days and after 100 days of natural killer (NK) treatment with or without total body irradiation.
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Within 100 days, After 100 days
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Overall Median Number of Days Patients Alive After Treatment
Time Frame: First Day of Treatment Until Death
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Calculated median number of days of survival (patients alive days after treatment).
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First Day of Treatment Until Death
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Collaborators and Investigators
Investigators
- Study Chair: Jeffrey Miller, MD, Masonic Cancer Center, University of Minnesota
- Principal Investigator: Sarah Cooley, MD, Masonic Cancer Center, University of Minnesota
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
- Interleukin-2
Other Study ID Numbers
- UMN-2005LS033
- UMN-0505M70037 (Other Identifier: IRB, University of Minnesota)
- UMN-MT2005-08 (Other Identifier: Blood and Bone Marrow Transplantation Program)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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