Busulfan, Melphalan, and Antithymocyte Globulin Followed By Umbilical Cord Blood Transplant in Treating Young Patients With Refractory or Relapsed Malignant Solid Tumors

NCT00436761 | Unknown Phase 1

• 2 other identifiers: CDR0000529361PSCI-18589
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy before a donor umbilical cord blood stem cell transplant helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's stem cells when they do not exactly match the patient's blood. The donated stem cells may replace the patient's immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and methylprednisolone after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects of busulfan, melphalan, and antithymocyte globulin followed by umbilical cord blood transplant in treating young patients with refractory or relapsed malignant solid tumors.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (2)

• Safety

• Incidence of graft-versus-host disease

Secondary Outcomes (2)

• Donor/host chimerism status

• Immune function post-transplant

Interventions

anti-thymocyte globulin BIOLOGICAL

graft-versus-tumor induction therapy BIOLOGICAL

sargramostim BIOLOGICAL

busulfan DRUG

cyclosporine DRUG

melphalan DRUG

methylprednisolone DRUG

flow cytometry OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

allogeneic hematopoietic stem cell transplantation PROCEDURE

umbilical cord blood transplantation PROCEDURE

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Diagnosis of malignant solid tumor * Relapsed or refractory disease * No isolated local recurrence of disease (in the site of the primary tumor) \> 1 year after completing therapy * No brain tumors or brain metastases * Unrelated cord blood donor available * May be HLA 6/6 matched (HLA-A, -B, -DR) OR mismatched for 1, 2, or 3 of these HLA loci, but must be mismatched for HLA-C group as indicated by their following killer cell immunoglobulin-like receptor (KIR) group specificity: * KIR2DL1 * Cw 2 * Cw 0307 * Cw 4, 5, 6 * Cw 0707, 0709 * Cw 1204, 1205 * All other Cw 15 alleles * Cw 1602 * Cw 17 * Cw 18 * KIR2DL2 * Cw 1 * All other Cw 3 alleles * All other Cw 7 alleles * Cw 8 * Cw 1202, 1203, 1206 * Cw 1301 * Cw 1402, 1403 * Cw 1507 * Cw 1601, 1604 * Cord blood specimen must have ≥ 1 x 10\^7 nucleated cells/kg patient ideal body weight PATIENT CHARACTERISTICS: * ECOG performance status (PS) 0-2 OR Lansky PS 70-100% * Cardiac ejection fraction ≥ 50% * Creatinine clearance ≥ 50% * Bilirubin ≤ 3.0 mg/dL * DLCO ≥ 70% OR O\_2 saturation ≥ 95% on room air PRIOR CONCURRENT THERAPY: * Prior autologous stem cell transplantation allowed

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 Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

MeSH Terms

Interventions

Antilymphocyte Serum; sargramostim; Busulfan; Cyclosporine; Melphalan; Methylprednisolone; Flow Cytometry; Immunologic Techniques; Cord Blood Stem Cell Transplantation

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; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; 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

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: May 1, 2004
• Last Updated: December 18, 2013

Record last verified: 2007-06

Locations

US (1)