Back to resultsDonor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors
Primary Purpose
Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin
busulfan
cyclosporine
melphalan
methotrexate
methylprednisolone
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
umbilical cord blood transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Neuroblastoma focused on measuring unspecified childhood solid tumor, protocol specific, recurrent neuroblastoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood rhabdomyosarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of relapsed or refractory solid tumor, including, but not limited to, relapsed neuroblastoma, relapsed Ewing's sarcoma, and relapsed rhabdomyosarcoma No isolated local disease recurrence at the site of the primary tumor > 1 year after completion of prior therapy No brain tumor or brain metastases Related or unrelated hematopoietic stem cell donor available, meeting 1 of the following criteria: Matched for HLA-A, -B, -C, -DR, and -DQ (9/10 or 10/10 allelles) (marrow or peripheral blood) Matched for HLA-A, -B, and -DR (5/6 or 6/6 allelles) (cord blood) Cord blood specimen must contain ≥ 2 x 10 ^7 nucleated cells/kg body weight PATIENT CHARACTERISTICS: Age 30 and under Performance status ECOG 0-1 OR Lansky 80-100% Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin ≤ 3.0 mg/dL Renal Creatinine clearance ≥ 50 mL/min Cardiovascular Ejection fraction ≥ 50% Pulmonary DLCO ≥ 70% OR O_2 saturation ≥ 95% on room air Other Not pregnant Negative pregnancy test Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy Prior autologous stem cell transplantation allowed Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified
Sites / Locations
- Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00112645
First Posted
June 2, 2005
Last Updated
July 17, 2013
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00112645
Brief Title
Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors
Official Title
A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
5. Study Description
Brief Summary
RATIONALE: A peripheral stem cell, bone marrow, or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving busulfan and melphalan with or without antithymocyte globulin before transplant and cyclosporine with methylprednisolone or methotrexate after transplant may stop this from happening.
PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating young patients with relapsed or refractory solid tumors.
Detailed Description
OBJECTIVES:
Determine the toxicity of allogeneic hematopoietic stem cell transplantation, in terms of the incidence of grade 3-4 acute graft-versus-host disease, in young patients with relapsed or refractory solid tumors.
Determine the incidence of transplant-related mortality at 100 days post-transplantation in these patients.
OUTLINE:
Conditioning: Patients receive busulfan IV or orally 4 times daily on days -8 to -5 (a total of 16 doses) and melphalan IV over 15-20 minutes on days -4 to -2. Patients with an unrelated donor also receive anti-thymocyte globulin IV on days -4 to -2.
Allogeneic hematopoietic stem cell transplantation (SCT): Patients undergo allogeneic hematopoietic SCT on day 0.
Post-transplant graft-versus-host disease (GVHD) prophylaxis: Patients who undergo cord blood SCT receive cyclosporine and methylprednisolone for graft-versus-host disease (GVHD) prophylaxis. Patients who undergo peripheral blood or bone marrow SCT receive cyclosporine and methotrexate (short course) for GVHD prophylaxis.
After completion of study treatment, patients are followed at 1, 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
unspecified childhood solid tumor, protocol specific, recurrent neuroblastoma, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood rhabdomyosarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
anti-thymocyte globulin
Intervention Type
Drug
Intervention Name(s)
busulfan
Intervention Type
Drug
Intervention Name(s)
cyclosporine
Intervention Type
Drug
Intervention Name(s)
melphalan
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
umbilical cord blood transplantation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of relapsed or refractory solid tumor, including, but not limited to, relapsed neuroblastoma, relapsed Ewing's sarcoma, and relapsed rhabdomyosarcoma
No isolated local disease recurrence at the site of the primary tumor > 1 year after completion of prior therapy
No brain tumor or brain metastases
Related or unrelated hematopoietic stem cell donor available, meeting 1 of the following criteria:
Matched for HLA-A, -B, -C, -DR, and -DQ (9/10 or 10/10 allelles) (marrow or peripheral blood)
Matched for HLA-A, -B, and -DR (5/6 or 6/6 allelles) (cord blood)
Cord blood specimen must contain ≥ 2 x 10 ^7 nucleated cells/kg body weight
PATIENT CHARACTERISTICS:
Age
30 and under
Performance status
ECOG 0-1 OR
Lansky 80-100%
Life expectancy
Not specified
Hematopoietic
Not specified
Hepatic
Bilirubin ≤ 3.0 mg/dL
Renal
Creatinine clearance ≥ 50 mL/min
Cardiovascular
Ejection fraction ≥ 50%
Pulmonary
DLCO ≥ 70% OR
O_2 saturation ≥ 95% on room air
Other
Not pregnant
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior autologous stem cell transplantation allowed
Chemotherapy
Not specified
Endocrine therapy
Not specified
Radiotherapy
Not specified
Surgery
Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth G. Lucas, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
12. IPD Sharing Statement
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Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors
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