Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor
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|ClinicalTrials.gov Identifier: NCT00638898|
Recruitment Status : Active, not recruiting
First Posted : March 19, 2008
Last Update Posted : May 7, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor Adult Central Nervous System Germ Cell Tumor Adult Rhabdomyosarcoma Childhood Central Nervous System Germ Cell Tumor Childhood Soft Tissue Sarcoma Ewing Sarcoma Metastatic Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Ovarian Mixed Germ Cell Tumor Previously Untreated Childhood Rhabdomyosarcoma Recurrent Adult Brain Tumor Recurrent Adult Soft Tissue Sarcoma Recurrent Childhood Brain Stem Glioma Recurrent Childhood Cerebellar Astrocytoma Recurrent Childhood Cerebral Astrocytoma Recurrent Childhood Ependymoma Recurrent Childhood Malignant Germ Cell Tumor Recurrent Childhood Medulloblastoma Recurrent Childhood Pineoblastoma Recurrent Childhood Supratentorial Primitive Neuroectodermal Tumor Recurrent Childhood Visual Pathway and Hypothalamic Glioma Recurrent Childhood Visual Pathway Glioma Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor Recurrent Extragonadal Germ Cell Tumor Recurrent Extragonadal Non-seminomatous Germ Cell Tumor Recurrent Malignant Testicular Germ Cell Tumor Recurrent Neuroblastoma Recurrent Ovarian Germ Cell Tumor Recurrent Wilms Tumor and Other Childhood Kidney Tumors Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific||Drug: busulfan Drug: melphalan Drug: topotecan hydrochloride Other: laboratory biomarker analysis Biological: filgrastim Procedure: autologous hematopoietic stem cell transplantation Other: pharmacological study Procedure: autologous bone marrow transplantation||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of High-Dose Chemotherapy With Busulfan, Melphalan, and Topotecan Followed by Autologous Hematopoietic Stem Cell Transplant in Advanced Stage and Recurrent Tumors|
|Study Start Date :||December 11, 2006|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Arm I
See Detailed Description
Drug: topotecan hydrochloride
Other: laboratory biomarker analysis
Given IV or subcutaneously
Procedure: autologous hematopoietic stem cell transplantation
Other: pharmacological study
Other Name: pharmacological studies
Procedure: autologous bone marrow transplantation
- Treatment feasibility in terms of investigational agent-related adverse events of a novel treatment combination followed by peripheral blood stem cell rescue [ Time Frame: Day 100 post stem cell rescue ]
- Overall survival [ Time Frame: 1 year post stem cell rescue ]
- Disease-free survival [ Time Frame: 1 year post stem cell rescue ]
- Incidence of myeloid and platelet engraftment [ Time Frame: Day 100 post stem cell rescue ]
- Pharmacokinetics and pharmacodynamics of topotecan hydrochloride and busulfan [ Time Frame: Baseline through day 4 of investigational agent treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638898
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|Principal Investigator:||Anna Pawlowska, MD||City of Hope Medical Center|