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

NCT00376805 | Terminated Phase 2 Results DMC

• 3 other identifiers: UMN-2005LS033UMN-0505M70037UMN-MT2005-08
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Breast Cancer

Keywords

stage IV breast cancer; male breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Who Had Expansion of Natural Killer Cells

  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

Secondary Outcomes (3)

• Number of Patients by Disease Response

  6 Months, 1 Year

• Number of Patients Who Died While on Study

  Within 100 days, After 100 days

• Overall Median Number of Days Patients Alive After Treatment

  First Day of Treatment Until Death

Study Arms (1)

All Treated Patients

EXPERIMENTAL

All patients with advanced metastatic breast cancer treated with natural killer cells after receiving fludarabine, cyclosphosphamide and total body irradiation.

Drug: Fludarabine; Drug: Cyclophosphamide; Radiation: Total body irradiation; Other: Natural killer cell infusion; Biological: Interleukin-2

Interventions

Fludarabine DRUG

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

Also known as: Fludara

All Treated Patients

Cyclophosphamide DRUG

administered intravenously 60 mg/kg days times 2 doses.

Also known as: Endoxan, Cytoxan, Neosar, Procytox

All Treated Patients

Total body irradiation RADIATION

200 cGy (gray) on day -1

Also known as: radiation

All Treated Patients

Natural killer cell infusion OTHER

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.

Also known as: NK cells

All Treated Patients

Interleukin-2 BIOLOGICAL

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

Also known as: IL-2

All Treated Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• At least 3 days since prior prednisone or other immunosuppressive medications
• No other concurrent therapy for cancer

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

fludarabine; fludarabine phosphate; Cyclophosphamide; Whole-Body Irradiation; Radiation; Interleukin-2

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Radiotherapy; Therapeutics; Investigative Techniques; Physical Phenomena; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Sarah Cooley, MD
• Organization: Masonic Cancer Center, University of Minnesota

cool0023@umn.edu

612-625-8474

Study Officials

• Jeffrey Miller, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

• Sarah Cooley, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: April 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: January 1, 2010
• Last Updated: December 28, 2017
• Results First Posted: August 12, 2010

Record last verified: 2017-12

Locations

US (1)