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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00638898 |
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 together with a stem cell transplant works in treating patients with newly diagnosed or relapsed solid tumor.
Condition | Intervention |
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Brain and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Kidney Cancer Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: busulfan Drug: filgrastim Drug: melphalan Drug: topotecan hydrochloride Procedure: autologous bone marrow transplantation Procedure: autologous hematopoietic stem cell transplantation Procedure: pharmacological study |
Study Type: | Interventional |
Study Design: | Treatment |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
Patients undergo blood sample collection periodically for pharmacological and pharmacodynamic studies.
After completion of study treatment, patients are followed every 3 months for 1 year and then annually thereafter.
Ages Eligible for Study: | up to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Relapsed disease, including any of the following:
Newly diagnosed, poor-risk pediatric solid tumors, including any of the following:
Other solid tumors, meeting the following criteria:
No histologically confirmed bone marrow metastases within 30 days prior to transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org |
Principal Investigator: | Ellen Bolotin, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000589296, CHNMC-03112 |
Study First Received: | March 18, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00638898 |
Health Authority: | Unspecified |
recurrent neuroblastoma adult rhabdomyosarcoma previously untreated childhood rhabdomyosarcoma recurrent adult brain tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor Ewing sarcoma recurrent adult soft tissue sarcoma adult central nervous system germ cell tumor ovarian mixed germ cell tumor recurrent childhood malignant germ cell tumor recurrent extragonadal germ cell tumor recurrent extragonadal non-seminomatous germ cell tumor recurrent malignant testicular germ cell tumor recurrent ovarian germ cell tumor metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor |
childhood soft tissue sarcoma unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific recurrent Wilms tumor and other childhood kidney tumors recurrent childhood cerebellar astrocytoma recurrent childhood cerebral astrocytoma recurrent childhood brain stem glioma recurrent childhood ependymoma recurrent childhood medulloblastoma recurrent childhood pineoblastoma recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood visual pathway and hypothalamic glioma recurrent childhood visual pathway glioma childhood central nervous system germ cell tumor adult central nervous system germ cell tumor |
Neuroectodermal Tumors, Primitive Malignant mesenchymal tumor Urogenital Neoplasms Nonseminomatous germ cell tumor Central Nervous System Neoplasms Urologic Neoplasms Neoplasms, Connective and Soft Tissue Ewing's sarcoma Neuroepithelioma Glioma Kidney Diseases Nervous System Neoplasms Rhabdomyosarcoma Endocrine Gland Neoplasms Astrocytoma |
Genital Neoplasms, Female Endocrine System Diseases Testicular Neoplasms Renal cancer Carcinoma Brain Neoplasms Neuroectodermal Tumors Sarcoma Testicular cancer Topotecan Neoplasms, Glandular and Epithelial Melphalan Gonadal Disorders Ewing's family of tumors Ovarian Diseases |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Nervous System Diseases Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Adnexal Diseases Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents |