Status:
WITHDRAWN
Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory High-Risk NBL.
Lead Sponsor:
Nationwide Children's Hospital
Conditions:
Neuroblastoma
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
Brief Summary
RATIONALE: - Relapsed or refractory Neuroblastoma (NBL) carries a very poor prognosis and children with relapsed NBL have an overall 3 year survival rate of \< 10%. Hematopoietic Stem Cell Transplant ...
Detailed Description
OBJECTIVES: Primary * To determine the feasibility of allogeneic hematopoietic stem cell transplantation after a reduced-intensity conditioning regimen comprising fludarabine phosphate, busulfan, an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of high-risk neuroblastoma, meeting one of the following criteria:
- Refractory disease, defined as no response, mixed response, or progressive disease after completion of induction therapy administered according to clinical trials COG-A3973 or COG-ANBL0532 (or other similar high-intensity induction regimen)
- Relapsed following high-dose chemoradiotherapy including autologous stem cell transplantation
- Achieved a complete remission (CR), very good partial remission (VGPR), or partial remission (PR) after ≤ 2 different salvage regimens, as defined by the following:
- In CR after treatment with some form of salvage therapy (e.g., ¹³¹I-MIBG, antibody-based therapy, or any other COG or NANT salvage-therapy regimen)
- In VGPR or PR after salvage therapy
- No more than 3 sites of skeletal disease as determined by an ¹²³I-MIBG scan (for regional involvement of the skeleton \[e.g., pelvis, spine\], the tumor involvement should be \< 25% of the site)
- Bone marrow involvement (\< 25% neuroblasts) by morphologic exam within the past 2 weeks
- Patients with soft tissue disease are eligible provided they exhibit either a VGPR or PR in the primary soft tissue mass and in any sites of metastatic soft tissue disease
- Disease status meeting one of the following criteria:
- Minimal residual disease
- Disease considered responsive to a salvage regimen
- Stable disease
- No rapidly progressive disease
- Donors must meet one of the following criteria:
- Matched, related donor (6/6 or 5/6) (bone marrow donor allowed)
- HLA-matched unrelated donor (10/10 match on high-resolution \[HR\] typing of HLA-A, B, C, DRB1, and DQB1)
- One allele- or antigen-mismatched unrelated donor (9/10 match on HR typing), mismatched at HLA-C only
- One allele- or antigen-mismatched unrelated donor (9/10 match on HR typing), mismatched at HLA-A, B, DRB1, or DQB1 (only when HLA-C mismatch is not available)
- PATIENT CHARACTERISTICS:
- Karnofsky/Lansky performance status 60-100%
- ANC \> 500/mm\^3
- Creatinine clearance or radioisotope GFR ≥ 60 mL/min
- Total bilirubin \< 3.0 mg/dL
- AST or ALT \< 5 times upper limit of normal
- Shortening fraction ≥ 25% by ECHO OR ejection fraction \> 30% by MUGA
- FEV\_1 and DLCO ≥ 30% OR normal chest x-ray, pulse oximetry, and venous blood gas
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active or recent (within the past 30 days) fungal infection
- No proven or suspected sepsis, pneumonia, or meningitis unless appropriate therapeutic measures have been initiated to control the infection and systemic signs are no longer life-threatening
- No requirement for oxygen or ventilator support
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior tandem autologous stem cell transplantations (according to clinical trial COG-ANBL0532) allowed
- No prior allogeneic hematopoietic stem cell transplantation
- More than 2 months since prior autologous stem cell transplantation, myeloablative therapy, total-body irradiation, whole abdominal radiotherapy, or therapeutic ¹³¹I-MIBG
- More than 3 weeks since prior chemotherapy, immunotherapy (including anti-GD2 regimen), or biologic response modifiers and recovered
- More than 2 weeks since prior local radiotherapy to the sites of metastatic disease
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00874315
Start Date
September 1 2008
End Date
June 1 2012
Last Update
October 16 2015
Active Locations (4)
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1
Children's Memorial Hospital
Chicago, Illinois, United States
2
Morgan Stanley Children's Hospital of NY
New York, New York, United States
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
4
Children's Hopsital of Wisconsin
Milwaukee, Wisconsin, United States