Clinical trial NCT00582816: Haploidentical Transplant With NK Cell Infusion for Pediatric Acute Leukemia and Solid Tumors
Official title: Reduced Intensity Haploidentical Transplantation With NK Cell Infusion for Pediatric Acute Leukemia and High Risk Solid Tumors, BMT06407
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Solid Tumors
Keywords: Recurrent or Refractory Leukemia or Solid Tumors in Pediatrics
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Miltenyi Biomedicine GmbH
First posted: 2007-12-28
Enrollment: 9
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the feasibility of utilizing a reduced intensity conditioning regimen, in the setting of haploidentical transplantation, for patients with recurrent acute lymphoblastic leukemia (ALL), AML and high risk or refractory solid tumors. In addition, the feasibility and safety of administering post-transplant NK cell infusions will be evaluated. Data obtained from this study will help determine the efficacy of allogeneic HSCT in the treatment of pediatric sarcomas and add to the small body of literature utilizing haploidentical HSCT to treat acute leukemia in pediatric patients. This study will also further elucidate the role of NK cells in mediating a graft vs. tumor effect in allogeneic HSCT. The main benefit to society is that this study will explore a novel therapy for children with highly refractory cancer who are felt to be incurable with conventional approaches. If feasibility is demonstrated, and there is evidence of anti-tumor activity, then this will open up a new area of clinical research to better define the efficacy of this approach for specific childhood malignancies.


Eligibility criteria: Inclusion Criteria:

* Solid tumors that have failed auto transplant or are ineligible to receive auto transplant
* Relapsed AML in 1st relapse or 2nd or 3rd CR
* Relapsed ALL if they fail to attain an initial remission or if they relapse within 1 year following the discontinuation of chemotherapy.
* Greater than or equal to 6 months and \<26 years old
* Suitable haploidentical donor available

Exclusion Criteria:

* Leukemia with \>25% blasts in bone marrow at the time of admission to the HSCT unit.
* Serum bilirubin \>3 mg/dl
* GFR \<40 ml/min/1.73 mw
* Cardiac left ventricular ejection fraction \<40%
* HIV+
* Pregnant

Primary outcomes:
measure: Grade III or IV GVHD
timeFrame: Day 100
measure: Engraftment Failure
timeFrame: 28 days
measure: Number of Days Until Engraftment Criteria Were Met
timeFrame: 28 days
measure: Mortality Rate
timeFrame: 100 days post-transplant
Secondary outcomes:
measure: NK Expression Levels
timeFrame: Up to 12 months
measure: Association Between Parental KIR Genotypes and NK Cell Cytotoxicities
timeFrame: Day 60
measure: Analysis of NK Cell KIR Expression Over Time
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: Kenneth DeSantes., MD
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Kenneth DeSantes, M.D.
role: PRINCIPAL_INVESTIGATOR
References: