Status:
COMPLETED
Pilot Study of Expanded, Donor Natural Killer Cell Infusions for Refractory Non-B Lineage Hematologic Malignancies and Solid Tumors
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Assisi Foundation
Conditions:
Leukemia, Myeloid, Acute
Leukemia, Lymphocytic, Acute, T-Cell
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE1
Brief Summary
Modern frontline therapy for patients with hematologic malignancies is based on intensive administration of multiple drugs. In patients with relapsed disease, response to the same drugs is generally p...
Detailed Description
Secondary objectives include the evaluation of the in vivo lifespan and phenotype of the expanded NK cells and explore the efficacy of these donor NK cells in study participants with relapsed or refra...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Less than or equal to 18 years of age (may be greater than 18 years of age if currently a St. Jude patient).
- Patients with relapsed or refractory AML, T-ALL/T-LL, mixed lineage leukemia, CML, JMML, MDS, ESFT or RMS who are not eligible for SCT and have persistent disease after remission induction(s) therapy as evidenced by bone marrow morphology, cytogenetics, flow cytometry, molecular pathology, and/or restaging scans.
- At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
- Shortening fraction greater than or equal to 25%.
- Creatinine clearance or glomerular filtration rate greater than or equal to 50 cc/min/1.73 m\^2.
- Pulse oximetry greater than or equal to 92% on room air.
- Direct bilirubin less than or equal to 3.0 mg/dL.
- Karnofsky or Lansky performance score of greater than or equal to 50.
- No known allergy to murine products or HAMA testing results within normal limits.
- Does not have a current pleural or pericardial effusion.
- Has a suitable adult family member donor available for NK cell donation.
- Is not receiving more than the equivalent of prednisone 10 mg daily.
- Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- Not breast feeding.
- Eligibility criteria prior to initiation of protocol therapy (preparative regimen)
- Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.
- Aspartate transaminase (AST) is no more than 2 times the upper limit of normal.
- Has recovered from all acute NCI Common Toxicity Criteria grade II-IV non-hematologic acute toxicities resulting from prior therapy per the judgment of the principal investigator
- Eligibility criteria (NK cell DONOR):
- Family member with a greater than or equal to 3 of 6 HLA match to recipient.
- At least 18 years of age.
- HIV negative.
- Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
- Not breast feeding.
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00640796
Start Date
September 1 2008
End Date
April 1 2014
Last Update
April 24 2014
Active Locations (1)
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1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105