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

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsored by: Milton S. Hershey Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112645
  Purpose

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.


Condition Intervention Phase
Neuroblastoma
Sarcoma
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: anti-thymocyte globulin
Drug: busulfan
Drug: cyclosporine
Drug: melphalan
Drug: methotrexate
Drug: methylprednisolone
Procedure: allogeneic bone marrow transplantation
Procedure: peripheral blood stem cell transplantation
Procedure: umbilical cord blood transplantation
Phase I

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Neuroblastoma    Soft Tissue Sarcoma   

ChemIDplus related topics:   Melphalan    Methotrexate    Methylprednisolone    Cyclosporine    Cyclosporin    Melphalan hydrochloride    Sarcolysin    Busulfan   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   A Phase I Study to Examine the Toxicity of Allogeneic Stem Cell Transplantation for Pediatric Solid Tumors With Relapsed or Therapy Refractory Disease

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:   10
Study Start Date:   April 2005
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

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.

  Eligibility
Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112645

Locations
United States, Pennsylvania
Penn State Cancer Institute at Milton S. Hershey Medical Center     Recruiting
      Hershey, Pennsylvania, United States, 17033-0850
      Contact: Kenneth G. Lucas, MD     717-531-6012     klucas@psu.edu    

Sponsors and Collaborators
Milton S. Hershey Medical Center

Investigators
Principal Investigator:     Kenneth G. Lucas, MD     Milton S. Hershey Medical Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000430441, PSCI-20615
First Received:   June 2, 2005
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00112645
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific  
recurrent neuroblastoma  
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor  
recurrent childhood rhabdomyosarcoma  

Study placed in the following topic categories:
Melphalan
Neuroectodermal Tumors, Primitive
Cyclosporine
Clotrimazole
Methylprednisolone
Miconazole
Malignant mesenchymal tumor
Ewing's family of tumors
Prednisolone acetate
Cyclosporins
Soft tissue sarcomas
Neuroblastoma
Neoplasms, Connective and Soft Tissue
Sarcoma, Ewing's
Ewing's sarcoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Methotrexate
Rhabdomyosarcoma
Methylprednisolone Hemisuccinate
Tioconazole
Methylprednisolone acetate
Recurrence
Folic Acid
Antilymphocyte Serum
Neuroectodermal Tumors
Peripheral neuroectodermal tumor
Busulfan
Prednisolone
Sarcoma

Additional relevant MeSH terms:
Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Reproductive Control Agents
Hormones
Neuroprotective Agents
Therapeutic Uses
Antifungal Agents
Abortifacient Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Glucocorticoids
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

ClinicalTrials.gov processed this record on October 03, 2008




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