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A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease


Phase 1
N/A
30 Years
Not Enrolling
Both
Neuroblastoma, Sarcoma, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Kenneth G. Lucas, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Milton S. Hershey Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000430441

NCT ID:

NCT00112645

Start Date:

April 2005

Completion Date:

Related Keywords:

  • Neuroblastoma
  • Sarcoma
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • unspecified childhood solid tumor, protocol specific
  • recurrent neuroblastoma
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent childhood rhabdomyosarcoma
  • Neuroblastoma
  • Neoplasms
  • Sarcoma

Name

Location

Penn State Hershey Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850