Status:
UNKNOWN
Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Unspecified Childhood Solid Tumor, Protocol Specific
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's ...
Detailed Description
OBJECTIVES: * 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 a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00436761
Start Date
May 1 2004
Last Update
December 18 2013
Active Locations (1)
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1
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850