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Sponsored by: |
New Approaches to Neuroblastoma Therapy Consortium |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005835 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of melphalan and buthionine sulfoximine followed by bone marrow or peripheral stem cell transplantation in treating children who have resistant or recurrent neuroblastoma.
Condition | Intervention | Phase |
---|---|---|
Neuroblastoma |
Biological: filgrastim Drug: buthionine sulfoximine Drug: melphalan Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Modulation of Intensive Melphalan (L-PAM) by Buthionine Sulfoximine (BSO) Autologous Stem Cell Support for Resistant or Recurrent High-Risk Neuroblastoma (IND 69-112) |
Estimated Enrollment: | 30 |
Study Start Date: | August 2001 |
Estimated Primary Completion Date: | November 2001 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of melphalan.
Patients receive buthionine sulfoximine IV as a bolus over 30 minutes followed by a 72-hour continuous infusion beginning on day -4; melphalan IV over 15 minutes on days -3 and -2; autologous peripheral blood stem cells or bone marrow IV over 15-30 minutes on day 0; and filgrastim (G-CSF) subcutaneously or IV once daily beginning on day 0 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed at 84 days and then 2 months later if there is a complete and/or partial response. Patients who continue therapy on other protocols are followed before starting the new therapy. All patients are followed for life for any delayed toxic effects to protocol therapy and secondary malignancies.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 years.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Meets 1 of the following response status criteria:
Meets 1 of the following criteria:
Bone marrow disease documented by standard morphology of bilateral bone marrow aspirate and biopsy specimens
Meets 1 of the following criteria for harvested autologous stem cells:
Availability of at least 1.0 x 10^6 viable CD34-positive purged autologous peripheral blood stem cells per kg of body weight*
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Neurologic:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
More than 6 months since prior radiotherapy to kidneys, liver, heart, skull, or face
Surgery:
Other:
United States, California | |
Childrens Hospital Los Angeles | Recruiting |
Los Angeles, California, United States, 90027-0700 | |
Contact: Judith G. Villablanca, MD 323-361-5654 jvillablanca@chla.usc.edu | |
Lucile Packard Children's Hospital at Stanford University Medical Center | Recruiting |
Palo Alto, California, United States, 94304 | |
Contact: Clare Twist, MD 650-723-5535 | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Katherine K. Matthay, MD 415-476-3831 | |
United States, Georgia | |
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: Howard M. Katzenstein, MD 404-785-0853 | |
United States, Illinois | |
University of Chicago Comer Children's Hospital | Recruiting |
Chicago, Illinois, United States, 60637 | |
Contact: Susan L. Cohn, MD 773-703-2571 scohn@peds.bsd.uchicago.edu | |
United States, Massachusetts | |
Children's Hospital Boston | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Suzanne Shusterman, MD 617-632-4901 suzanne_shusterman@dfci.harvard.edu | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Gregory Yanik, MD 734-936-8785 gyanik@umich.edu | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | Recruiting |
Cincinnati, Ohio, United States, 45229-3039 | |
Contact: John P. Perentesis, MD 513-636-6090 john.perentesis@chmcc.org | |
United States, Pennsylvania | |
Children's Hospital of Philadelphia | Recruiting |
Philadelphia, Pennsylvania, United States, 19104-4318 | |
Contact: John M. Maris, MD 215-590-5242 maris@chop.edu | |
United States, Washington | |
Children's Hospital and Regional Medical Center - Seattle | Recruiting |
Seattle, Washington, United States, 98105 | |
Contact: Julie R. Park, MD 206-987-2106 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Recruiting |
Madison, Wisconsin, United States, 53792-6164 | |
Contact: Paul M. Sondel, MD, PhD 608-263-9069 pmsondel@humonc.wisc.edu |
Study Chair: | Judith G. Villablanca, MD | Children's Hospital Los Angeles |
Study ID Numbers: | CDR0000067849, NANT-99-02, CHLA-LA-NANT-99-02, CHLA-CCI-00.020 |
Study First Received: | June 2, 2000 |
Last Updated: | February 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00005835 History of Changes |
Health Authority: | Unspecified |
regional neuroblastoma disseminated neuroblastoma recurrent neuroblastoma localized unresectable neuroblastoma |
Antimetabolites Melphalan Radiation-Protective Agents Neuroectodermal Tumors, Primitive Immunologic Factors Buthionine Sulfoximine Immunosuppressive Agents Neuroblastoma Recurrence |
Neuroectodermal Tumors Radiation-Sensitizing Agents Neoplasms, Germ Cell and Embryonal Neuroepithelioma Antineoplastic Agents, Alkylating Alkylating Agents Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Antimetabolites Melphalan Radiation-Protective Agents Neuroectodermal Tumors, Primitive Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Neuroblastoma Neoplasms, Germ Cell and Embryonal Therapeutic Uses Alkylating Agents |
Neoplasms by Histologic Type Buthionine Sulfoximine Enzyme Inhibitors Protective Agents Immunosuppressive Agents Pharmacologic Actions Neuroectodermal Tumors Neoplasms Radiation-Sensitizing Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |