Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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 stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methylprednisolone after the transplant may stop this from happening.

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Antilymphocyte Serum; Busulfan; Cyclosporine; Cyclosporins; Melphalan; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Sargramostim

Criteria

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