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CompletedNCT00112645Updated Jul 18, 2013

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

A Phase 1 interventional study of anti-thymocyte globulin and busulfan in Neuroblastoma, Sarcoma and Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged Up to 30 Years. Per ClinicalTrials.gov, last updated 2013-07-18.

Sponsored by Milton S. Hershey Medical Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Ages
Up to 30 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Neuroblastoma

634 studies on the registry are indexed under Neuroblastoma; 122 are open to participants now.

This study's planned enrollment of 10 is below the median of 32 across 480 interventional studies indexed under Neuroblastoma.

Browse Neuroblastoma studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 491 studies on the registry; 59 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 44 (76%) have results posted.

Browse Milton S. Hershey Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 30 Years
Sexes eligible
All
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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
Enrollment
10 participants (estimated)

Interventions

06

Study locations

1 site
  • Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033-0850, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00112645
Lead sponsor
Milton S. Hershey Medical Center
First posted
Jun 3, 2005
Start date
Apr 2005
Primary completion
Apr 2010
Completion
Feb 2011
Last update
Jul 18, 2013

Study contacts

Kenneth G. Lucas, MD
principal investigator · Milton S. Hershey Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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