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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma  Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma
Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma
For Condition: recurrent neuroblastoma,disseminated neuroblastoma,localized unresectable neuroblastoma,localized resectable neuroblastoma,regional neuroblastoma,stage 4S neuroblastoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving the drugs in different ways may kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by stem cell transplant and radiation therapy in treating patients who have neuroblastoma that has not responded to previous treatments.
Details: OBJECTIVES: - Determine the maximum tolerated dose and toxic effects of iodine I 131 metaiodobenzylguanidine (131 I-MIBG) plus ablative doses of carboplatin and etoposide administered with fixed-dose melphalan followed by autologous hematopoietic stem cell transplantation in patients with refractory or residual high-risk neuroblastoma. - Determine the number of days until blood counts recover in these patients after receiving this treatment regimen. - Determine the response rate to this treatment regimen in these patients. - Determine the tumor dosimetry of 131 I-MIBG in patients with measurable soft tissue lesions. OUTLINE: This is a dose-escalation study of iodine I 131 metaiodobenzylguanidine (131 I-MIBG), carboplatin, and etoposide. Patients are stratified according to glomerular filtration rate (at least 100 mL/min vs 60-99 mL/min). Patients undergo peripheral blood stem cell harvest or bone marrow harvest at least 2 weeks prior to treatment with 131 I-MIBG. Patients receive 131 I-MIBG IV over 120 minutes on day -21; melphalan IV on days -7 to -5; carboplatin and etoposide IV continuously over 96 hours on days -7 to -4; autologous hematopoietic stem cell transplantation IV over 15-30 minutes on day 0; and filgrastim (G-CSF) subcutaneously or IV starting on day 0 and continuing until blood counts recover. Radiotherapy is administered to the primary tumor site and metastatic sites twice daily for 7 consecutive days within 6 weeks of transplantation or once blood counts have recovered. Cohorts of 3-6 patients receive escalating doses of 131 I-MIBG, carboplatin, and etoposide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at days 84, 144, and 204 and then at 6, 12, 18, 24, 36, and 60 months. PROJECTED ACCRUAL: A total of 30-60 patients (15-30 per stratum) will be accrued for this study within 2-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of neuroblastoma as evidenced by one of the following: - Histological confimation - Demonstrates clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites - High-risk refractory or residual disease - Poorly responding disease, meeting 1 of the following criteria: - Stable disease or partial response after at least 12 weeks of induction therapy - Bone marrow containing greater than 100 tumor cells per 100,000 normal cells after 12 weeks of induction therapy - Progressive disease during or after therapy - At least 1 prior positive iodine I 131 metaiodobenzylguanidine (131 I-MIBG) scan since diagnosis and meets disease status criteria PATIENT CHARACTERISTICS: Age: - 1 to 21 (1 to 20 at diagnosis) Performance status: - ECOG 0-2 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 8 g/dL (transfusion allowed) Hepatic: - Bilirubin normal - AST/ALT no greater than 3 times normal Renal: - Glomerular filtration rate or creatinine clearance at least 60 mL/min - Creatinine less than 1.5 times normal for age Cardiovascular: - Ejection fraction at least 55% OR - Fractional shortening at least 30% Pulmonary: - No dyspnea at rest or exercise intolerance - No requirement for supplemental oxygen Other: - No disease of any major organ system that would preclude study participation - Not HIV positive with active health problems (e.g., hepatitis or pneumonia) - No active infections requiring intravenous antivirals, antibiotics, or antifungals - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic therapy and recovered Chemotherapy: - At least 3 weeks since prior chemotherapy and recovered - No more than 100 mg/m^2 total dose of prior melphalan Endocrine therapy: - Not specified Radiotherapy: - No prior total body, whole abdominal, or whole liver irradiation - No prior 131 I-MIBG - At least 2 weeks since prior radiotherapy (6 months for prior radiotherapy to craniospinal or whole lung fields or greater than 50% of bone marrow space) and recovered Surgery: - Prior surgical resection allowed - Recovered from prior surgery Other: - No prior myeloablative therapy - Prior submyeloablative therapy with peripheral blood stem cell support allowed - No concurrent antiretrovirals for HIV-positive patients - Concurrent prolonged antifungal allowed if culture and biopsy negative in suspected residual radiographic lesions - No medications that may preclude uptake of 131 I-MIBG for 1 week prior and 2 weeks after administration of study drugs - No concurrent hemodialysis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KatherineMatthay, Study Chair, Children's Hospital Los Angeles
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Julie Park 206-987-1947
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Katherine Matthay 415-476-3831
Children's Hospital Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lisa Diller 617-632-3725
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Terry Vik 317-274-8967
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4586
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-6090
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting John Maris 215-590-5242
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-4586
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Judith Villablanca 323-669-5654
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Susan Cohn 773-880-4562
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0942
United States
Recruiting Gregory Yanik 734-936-8785
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Clare Twist 650-723-5535
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *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
Additional Information:
Study ID Numbers: CDR0000067966; CHLA-LA-NANT-99-01,NANT-99-01,NCI-V00-1592
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005978
Other Recurrent Neuroblastoma Studies:
1. Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With Primitive Neuroectodermal Tumors
2. Monoclonal Antibody Therapy With Sargramostim and Interleukin-2 in Treating Children With Neuroblastoma
3. Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
4. Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
5. Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Neuroblastoma
Related Studies:
Other recurrent neuroblastoma Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma
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