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

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.

Conditions

• 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

Interventions

DRUG

busulfan

Given IV

DRUG

melphalan

Given IV

DRUG

topotecan hydrochloride

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

BIOLOGICAL

filgrastim

Given IV or subcutaneously

PROCEDURE

autologous hematopoietic stem cell transplantation

Undergo transplantation

OTHER

pharmacological study

Correlative studies

PROCEDURE

autologous bone marrow transplantation

Undergo transplantation

Sponsors & Collaborators

• City of Hope Medical Center

  lead OTHER

Principal Investigators

• Anna Pawlowska, MD · City of Hope Medical Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Months

Max Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-26

Primary Completion

2013-01-19

Completion

2024-12-10

Countries

• United States

Study Locations