Clinical Trials Directory

Trials / Completed

CompletedNCT00638898

Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor

Pilot Study of High-Dose Chemotherapy With Busulfan, Melphalan, and Topotecan Followed by Autologous Hematopoietic Stem Cell Transplant in Advanced Stage and Recurrent Tumors

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
25 (actual)
Sponsor
City of Hope Medical Center · Academic / Other
Sex
All
Age
6 Months – 40 Years
Healthy volunteers
Not accepted

Summary

RATIONALE: Giving high-dose chemotherapy before an autologous stem cell transplant stops the growth of tumor cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. Chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This clinical trial is studying how well giving busulfan, melphalan, and topotecan hydrochloride together with a stem cell transplant works in treating patients with newly diagnosed or relapsed solid tumor.

Detailed description

OBJECTIVES: I. To assess the feasibility of a novel combination conditioning therapy with busulfan/melphalan and topotecan followed by autologous hematopoietic stem cell transplantation (HSCT) in patients with relapsed, refractory and/or poor risk pediatric solid tumors. II. To determine within the confines of this pilot study, myeloid and platelet engraftment, overall survival and disease-free survival in patients with relapsed, refractory pediatric solid tumors and in patients who have solid tumors with poor risk factors at the time of diagnosis. III. To determine the pharmacokinetics of topotecan. OUTLINE: AUTOLOGOUS HEMATOPOIETIC STEM CELL OR AUTOLOGOUS BONE MARROW COLLECTION: Patients undergo stem cell mobilization per institutional guidelines with G-CSF IV or subcutaneously, continuing until the completion of leukapheresis. Patients undergo apheresis after mobilization and continue until a minimum of 2.0 x 10\^6 CD34 cells/kg or more are collected. Cells are processed and cryopreserved following institutional guidelines. Patients who collect \> 2.0 x 10\^6 CD34+ cells/kg may proceed to high-dose chemotherapy. HIGH-DOSE CHEMOTHERAPY: Patients receive topotecan hydrochloride IV continuously over 24 hours on days -8 to -4, busulfan IV every 6 hours on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. AUTOLOGOUS HEMATOPOIETIC STEM CELL OR AUTOLOGOUS BONE MARROW REINFUSION: Patients undergo autologous hematopoietic stem cell transplantation or autologous bone marrow transplantation on day 0. Patients also receive G-CSF IV daily beginning on day +5 and continuing until blood counts recover. After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter.

Conditions

Interventions

TypeNameDescription
DRUGbusulfanGiven IV
DRUGmelphalanGiven IV
DRUGtopotecan hydrochlorideGiven IV
OTHERlaboratory biomarker analysisCorrelative studies
BIOLOGICALfilgrastimGiven IV or subcutaneously
PROCEDUREautologous hematopoietic stem cell transplantationUndergo transplantation
OTHERpharmacological studyCorrelative studies
PROCEDUREautologous bone marrow transplantationUndergo transplantation

Timeline

Start date
2007-02-26
Primary completion
2013-01-19
Completion
2024-12-10
First posted
2008-03-19
Last updated
2025-03-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00638898. Inclusion in this directory is not an endorsement.