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Protocol No. UW16009

Principal Investigator DeSantes, Kenneth

Phase I

Age Group Both

Scope Local

Sponsor Type Externally Peer-Reviewed; Institutional

Title Treatment of Relapsed or Refractory Neuroblastoma with Ex-Vivo Expanded and Activated Haploidentical NK Cells and Hu14.18-IL2

Objective The main purpose of this study is to find out if this new treatment is safe. We hope that the treatment in this study will have an anti-neuroblastoma effect, but whether or no this therapy works to treat neuroblastoma has not yet been tested.

Treatment Fresh/thawed EA-NK cells in conjunction with hu14.18-IL2

Description Treatment of Relapsed or Refractory Neuroblastoma with Ex-Vivo Expanded and Activated Haploidentical NK Cells(EA-NK) and Hu14.18-IL2

Key Eligibility
  • Patients must be greater than 6 months of age or 21 years or younger at the time of study enrollment
  • The target tumor is limited to neuroblastoma. Patients must have had histologic verification of neuroblastoma and/or demonstration of tumor cells in the bone marrow with increased urinary catecholamines at the time of initial diagnosis
  • Patients must have resistant/refractory or recurrent neuroblastoma
  • Karnofsky > 50 for patients > 16 years of age and Lansky > 50 for patients ≤16 years of age
  • Patients must have a life expectancy of ≥ 4 months
  • Patients are eligible > 100 days after autologous stem cell infusion following myeloablative therapy. Patients receiving an autologous stem cell infusion to support non-myeloablative therapy (including 131I-MIBG given as a single agent) are eligible > 6 weeks following the stem cell infusion provided they meet the hematologic and other organ function criteria for eligibility. Patients who have received an allogeneic stem cell transplant are excluded
  • Patients must not have received growth factor(s) within 1 week of entry onto this study
  • Adequate bone marrow, renal, liver, cardiac and pulmonary function
  • Patients with a history of central nervous system disease must have no clinical or radiological evidence of CNS disease at the time of protocol enrollment and with
  • CNS toxicity ≤ Grade 2. Patients with seizure disorders may be enrolled if seizures are well controlled
  • Sexually active patients must agree to use an effective birth control method for the duration of the study

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Liver; Lung; Melanoma/Skin cancer; Ovary; Pancreas; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics