Donor Stem Cell Transplant in Treating Young Patients With Relapsed or Refractory Solid Tumors

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

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