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

NCT00112645 | Completed Phase 1

• 2 other identifiers: PSCI-20615CDR0000430441
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Interventions

anti-thymocyte globulin BIOLOGICAL

busulfan DRUG

cyclosporine DRUG

melphalan DRUG

methotrexate DRUG

methylprednisolone DRUG

allogeneic bone marrow transplantation PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

umbilical cord blood transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Conditions

Neuroblastoma; Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Antilymphocyte Serum; Busulfan; Cyclosporine; Melphalan; Methotrexate; Methylprednisolone; Peripheral Blood Stem Cell Transplantation; Cord Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Kenneth G. Lucas, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: April 1, 2005
• Primary Completion: April 1, 2010
• Study Completion: February 1, 2011
• Last Updated: July 18, 2013

Record last verified: 2011-02

Locations

US (1)