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Phase 2 N=13 Treatment

Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer

Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cancer · Breast Cancer

Enrolled (actual)
13
Serious AEs
84.6%
Results posted
Feb 2017
Primary outcome: Primary: Response Rate — 1; 2; 4 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Fludarabine (Drug); Cyclophosphamide (Drug); Cyclosporine (Drug); Natural killer cells (Biological); IL-2 (Drug); Methylprednisolone (Drug); Interleukin-2 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Masonic Cancer Center, University of Minnesota
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Response Rate
1; 2; 4
SECONDARY
Time to Disease Progression
52; 98; 100
SECONDARY
Number of Participants With Progressive Disease at One Year
2; 1; 5
SECONDARY
Overall Survival
0; 1; 3

Summary

This is a single center phase II trial designed to optimize a clinical platform of lymphodepleting chemotherapy and T-cell suppression to promote the persistence, function, and expansion of allogeneic natural killer (NK) cells in patients with recurrent ovarian, fallopian tube, primary peritoneal cancer and advanced metastatic breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of recurrent ovarian cancer, fallopian tube, or primary peritoneal cancer that has failed or progressed after at least 2 prior salvage chemotherapy regimens (directed at recurrent/metastatic disease).

OR

  • Diagnosis of metastatic breast cancer (female or male) that has progressed on or failed at least one salvage chemotherapy regimen for metastatic disease and that meets the following disease specific related criteria:
  • If estrogen receptor or progesterone receptor positive must have progressed on prior hormonal therapy and/or
  • if HER2-neu positive must have progressed on trastuzumab, lapatinib, or similar agent

Women with a history of both cancers are eligible for this study provided that they currently meet eligibility for one of the diseases. Women who have had another malignancy and have been disease free for at least 3 year, or with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.

  • Measurable disease per disease specific Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 - patients with bone as their only site of disease will not be eligible.
  • If history of brain metastases must be stable for at least 3 months after treatment - A brain computed tomography (CT) scan will only be required in subjects with known brain metastases at the time of enrollment or in subjects with clinical signs or symptoms suggestive of brain metastases.
  • Available related HLA-haploidentical natural killer (NK) cell donor (by at least class I serologic typing at the A&B locus)
  • Age 18 years or older
  • Karnofsky performance status > or = 50%
  • Adequate organ function as determined by the following criteria within 14 days of study enrollment
  • Bone marrow: platelets > or = 80,000 x 10^9/L and hemoglobin > or = 9 g/dL, unsupported by transfusions; absolute neutrophil count (ANC) > or = 1000 x 10^9/L, unsupported by growth colony stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
  • Renal function: creatinine (Cr) 40% (within 28 days of treatment start)
  • Pulmonary function: >50% corrected Carbon Monoxide Diffusing Capacity (DLCO) and Forced Expiratory Volume in One Second (FEV1), if presence of pleural effusion due to metastatic disease >40% corrected DLCO and FEV1 is acceptable (within 28 days of treatment start)
  • Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to Day 0
  • At least 14 days must lapse between last prior anti-cancer treatment and 1st day of preparative regimen
  • Voluntary written informed consent

Exclusion Criteria

  • Pregnant or nursing - The agents used in this study may be teratogenic to a fetus and there is no information on the excretion of agents into breast milk. Participants of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy and agree to use adequate birth control during study treatment
  • Active infection - subjects must be afebrile, off antibiotics, and with no uninvestigated radiologic lesions (infiltrates or lesions with negative cultures or biopsies) are allowed
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01105650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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