Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors
NCT ID: NCT00436761
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2004-05-31
Brief Summary
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PURPOSE: This phase I trial is studying the side effects of busulfan, melphalan, and antithymocyte globulin followed by umbilical cord blood transplant in treating young patients with refractory or relapsed malignant solid tumors.
Detailed Description
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* Examine the impact of the use of killer cell immunoglobulin-like receptor (KIR)-mismatched umbilical cord blood as a source of hematopoietic stem cells, after busulfan, melphalan, and anti-thymocyte globulin in pediatric patients with relapsed or refractory solid tumors.
* Determine the toxicity of this regimen, in terms of incidence of grade 3-4 acute graft-versus-host disease, donor/host chimerism, and cellular immunity against tumor cell lines, in these patients.
OUTLINE:
* Transplantation: Patients receive busulfan orally or IV every 6 hours on days -8 to -5, anti-thymocyte globulin IV over 6 hours on days -4 to -1, and melphalan IV over 15-20 minutes on days -4 to -2. Patients undergo allogeneic umbilical cord blood stem cell infusion on day 0. Patients receive sargramostim (GM-CSF) subcutaneously beginning on day 7 and continuing until blood counts recover.
* Graft-vs-host disease prophylaxis: Patients receive cyclosporine IV over 1 hour or orally twice daily on days -1 to 180 and methylprednisolone IV or orally once or twice daily on days 5 - 49.
Blood samples are collected periodically for immunophenotyping and flow cytometric analysis (including interferon gamma and other TH1 and TH2 cytokines).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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anti-thymocyte globulin
graft-versus-tumor induction therapy
sargramostim
busulfan
cyclosporine
melphalan
methylprednisolone
flow cytometry
immunologic technique
laboratory biomarker analysis
allogeneic hematopoietic stem cell transplantation
umbilical cord blood transplantation
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of malignant solid tumor
* Relapsed or refractory disease
* No isolated local recurrence of disease (in the site of the primary tumor) \> 1 year after completing therapy
* No brain tumors or brain metastases
* Unrelated cord blood donor available
* May be HLA 6/6 matched (HLA-A, -B, -DR) OR mismatched for 1, 2, or 3 of these HLA loci, but must be mismatched for HLA-C group as indicated by their following killer cell immunoglobulin-like receptor (KIR) group specificity:
* KIR2DL1
* Cw 2
* Cw 0307
* Cw 4, 5, 6
* Cw 0707, 0709
* Cw 1204, 1205
* All other Cw 15 alleles
* Cw 1602
* Cw 17
* Cw 18
* KIR2DL2
* Cw 1
* All other Cw 3 alleles
* All other Cw 7 alleles
* Cw 8
* Cw 1202, 1203, 1206
* Cw 1301
* Cw 1402, 1403
* Cw 1507
* Cw 1601, 1604
* Cord blood specimen must have ≥ 1 x 10\^7 nucleated cells/kg patient ideal body weight
PATIENT CHARACTERISTICS:
* ECOG performance status (PS) 0-2 OR Lansky PS 70-100%
* Cardiac ejection fraction ≥ 50%
* Creatinine clearance ≥ 50%
* Bilirubin ≤ 3.0 mg/dL
* DLCO ≥ 70% OR O\_2 saturation ≥ 95% on room air
PRIOR CONCURRENT THERAPY:
* Prior autologous stem cell transplantation allowed
21 Years
ALL
No
Sponsors
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Milton S. Hershey Medical Center
OTHER
Principal Investigators
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Kenneth G. Lucas, MD
Role: STUDY_CHAIR
Milton S. Hershey Medical Center
Locations
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Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Countries
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Other Identifiers
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PSCI-18589
Identifier Type: -
Identifier Source: secondary_id
CDR0000529361
Identifier Type: -
Identifier Source: org_study_id