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Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma Clinical research trials and Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma. Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma  Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma
Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma
For Condition: regional neuroblastoma,recurrent neuroblastoma,disseminated neuroblastoma,localized unresectable neuroblastoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 recurrent or refractoryneuroblastoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of melphalan when combined with buthionine sulfoximine and followed by autologous bone marrow or peripheral blood stem cell support in children with recurrent or refractory high-risk neuroblastoma. - Assess the toxic effects of this regimen in these patients. - Determine the pharmacokinetics of this regimen in these patients. - Determine the response rate of patients treated with this regimen. OUTLINE: This is a multicenter, dose-escalation study of melphalan. Patients receive buthionine sulfoximine IV continuously for 72.5 hours 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 every 2 months for the next 4 months if there is a complete and/or partial response. Patients who continue therapy on other protocols are followed before starting the new therapy. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /18 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of high-risk neuroblastoma confirmed by histology and/or tumor cells in bone marrow with elevated urinary catecholamine metabolites - Refractory to conventional therapy or other therapies of higher priority - Disease progression with failure to respond or disease progression after standard salvage therapy OR - Underwent prior hematopoietic stem cell transplantation at least 6 months ago with failure to respond or disease progression after standard salvage therapy - Availability of at least 1.5 x 10 - CD34-positive purged/unpurged autologous peripheral blood stem cells per kg of body weight OR - Availability of at least 1 x 10^8 purged autologous mononuclear bone marrow cells per kg of body weight - No history of intraparenchymal brain lesion - No concurrent intraparenchymal brain lesion or meningeal/parameningeal soft tissue mass extending directly into the cranial cavity by CT, MRI, or 3-iodobenzylguanidine scan PATIENT CHARACTERISTICS: Age: - Over 9 months to 18 years Performance status: - ECOG or Zubrod 0-1 Life expectancy: - At least 2 months Hematopoietic: - Absolute neutrophil count at least 500/mm^3 - Platelet count at least 20,000/mm^3 (transfusion allowed) - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic: - Bilirubin normal - AST and ALT no greater than 2.5 times normal - No active hepatitis if HIV positive Renal: - Glomerular filtration rate or creatinine clearance at least 80 mL/min - Creatinine normal - No history of grade 2 or greater creatinine elevation during prior antibiotic therapy within the past 6 months Cardiovascular: - Ejection fraction at least 55% by echocardiogram or MUGA scan OR - Fractional shortening at least 30% by echocardiogram Pulmonary: - No dyspnea at rest or exercise intolerance - No active pneumonia if HIV positive Neurologic: - No grade 1 or greater neurological function abnormality except grade 1 irritability, headache, dizziness, insomnia, or somnolence (if due to narcotic analgesics) - No history of seizures Other: - No other active health problems if HIV positive - No concurrent neoplastic or nonneoplastic disease of any major organ system that would preclude study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 3 weeks since prior biologic therapy and recovered Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered - No other concurrent anticancer chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Recovered from prior radiotherapy - More than 6 months since prior radiotherapy to any of the following fields: - Mandible (no greater than 1,000 cGy) - Mantle and Y ports - At least 2 weeks since prior radiotherapy to all other sites - Prior abdominal radiotherapy allowed if at least 1 entire kidney has not been exposed to therapeutic radiotherapy of any form - Prior diagnostic radiotherapy allowed - No prior radiotherapy to the brain (including craniospinal, whole brain, or to a craniofacial metastasis except the mandible) - No concurrent radiotherapy Surgery: - Not specified Other: - Recovered from any prior therapy - No concurrent antiretroviral medications for HIV-positive patients - No acetaminophen, antibiotics (including cephalosporins), antifungals, or antivirals for at least 1 week before, during, or for at least 2 weeks after buthionine sulfoximine infusion
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ClarkeAnderson, Study Chair, Children's Hospital Los Angeles
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lisa Diller 617-632-5642
Children's Hospital Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lisa Diller 617-632-3725
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Howard Katzenstein 404-727-4451
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Clare Twist 650-723-5535
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-6016
United States
Recruiting Clarke Anderson 323-669-4112
University of California-San Francisco School of Medicine *Recruiting*
San Francisco, California, 94143-0410
United States
Recruiting Katherine Matthay 415-476-3831
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting John Maris 215-590-5242
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting Paul Sondel 608-263-9069
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Julie Park 206-987-1947
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0942
United States
Recruiting Gregory Yanik 734-936-8785
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Susan Cohn 773-880-4562
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4586
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-6090
James Whitcomb Riley Hospital for Children *Recruiting*
Indianapolis, Indiana, 46202-5225
United States
Recruiting Terry Vik 317-274-8967
Additional Information:
Study ID Numbers: CDR0000067849; NANT-99-02,CHLA-LA-NANT-99-02,NCI-68
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005835
Other Regional Neuroblastoma Studies:
1. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
2. Fenretinide in Treating Children With Solid Tumors
3. Multiple Therapies in Treating Patients With Advanced Neuroblastoma
4. Monoclonal Antibody 3F8 and Sargramostim in Treating Patients With Neuroblastoma
5. Vinorelbine in Treating Children With Recurrent or Refractory Cancers
Related Studies:
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Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma
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