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Haploidentical Natural Killer (NK) Cells in Patients With Relapsed or Refractory Neuroblastoma

NCT00698009 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-09-24

Study results available
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Summary

Primary:

Evaluate safety, feasibility, persistence, and anti-tumor effect of infused haploidentical donor-derived natural killer (NK) cells and low-dose interleukin-2 (IL-2).

Secondary:

* Quantification of cytokine levels;
* Assessment of NK cell immunophenotype and function.

Conditions

Interventions

DRUG

Fludarabine

25 mg/m\^2 By Vein Daily Over 30 minutes Starting 6 days before the NK cell infusion (considered Day -6) and once a day through Day -2.

DRUG

Cyclophosphamide

60 mg/kg By Vein Daily Over 2 Hours On Days -5 and -4

BIOLOGICAL

Natural Killer Cell Infusion

Natural Killer Cell Infusion on Day 0.

DRUG

Mesna

12 mg/kg By Vein, Over about 15 minutes, Five Times Per Day on Days -5 and -4.

DRUG

Interleukin-2

Received under skin three times weekly for 9 total doses following NK Cell Infusion: For patients weighing 45 kg or more, dose administered is 10 Million units three times weekly for 9 total doses. For patients less than 45 kg, dose administered is 5 Million units/m2 (max dose 10 Million units) three times weekly for 9 total doses.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Susan S. Kelly, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

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 NCT00698009 on ClinicalTrials.gov