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Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma Clinical research trials and Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma. Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma clinical trial. Human subjects often get the best healthcare possible for their Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma  Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
For Condition: localized unresectable neuroblastoma,regional neuroblastoma,stage 4S neuroblastoma,disseminated neuroblastoma,localized resectable neuroblastoma
Status: No longer recruiting
Sponsor(s): University of Cologne ,
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 transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which treatment regimen is most effective in treating patients with different stages of and risk factors for neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of therapy based on stage of disease and risk assessment in treating children with neuroblastoma.
Details: OBJECTIVES: I. Increase the survival rates and duration of survival in children and adolescents with neuroblastoma by using stage- and risk group-appropriate therapy. II. Determine whether using cisplatin/etoposide/vindesine and vincristine/dacarbazine/ifosfamide/doxorubicin instead of cisplatin/teniposide and vincristine/dacarbazine/cyclophosphamide/doxorubicin improves remission rate and lessens toxicity in patients with stage 3C, 3D, or 4 neuroblastoma. III. Determine whether local radiotherapy to the primary tumor and bone metastasis improves local tumor control in these patients. IV. Compare the efficacy and survival associated with short-term, high-dose conditioning chemotherapy plus autologous bone marrow transplantation vs. long-term, low-dose cytostatic chemotherapy as consolidation therapy in these patients. V. Determine whether early use of low-dose doxorubicin/vincristine plus hepatic irradiation slows disease progression in patients with stage 4S-C neuroblastoma. VI. Determine whether 4 courses of chemotherapy reduces the occurrence of local and systemic relapse in patients with stages 2, 3A, and 3B neuroblastoma. VII. Determine whether serum tumor markers (LDH, catecholamine metabolites, and neuron-specific enolase) are predictive of remission behavior. PROTOCOL OUTLINE: Patients are staged according to the International Neuroblastoma Staging System and are further defined by progressively less favorable risk groups based on age at diagnosis, serum LDH, and tumor resectability (risk groups A, B, C, and D, representing presence of 0, 1, 2, or 3 risk factors, respectively). Patients who are unable to be resected at entry or with incomplete resection are re-evaluated at 4-month intervals for the appropriateness of tumor resection. STAGE 1 PATIENTS Patients undergo complete primary tumor resection and no other therapy. STAGES 2, 3A, AND 3B PATIENTS Patients undergo primary tumor resection, followed by cisplatin, etoposide, vindesine (PEV) alternating monthly with vincristine, dacarbazine, ifosfamide, doxorubicin (VDIA). Patients in complete remission (CR) discontinue therapy, while those with less than CR receive additional therapy as outlined below for stages 3C, 3D, and 4 patients, except that these patients are not eligible for bone marrow transplantation. STAGES 3C, 3D, AND 4 PATIENTS Patients receive PEV and VDIA as above, with radiotherapy to sites of metastases during the third and fourth courses, following which autologous bone marrow is collected. Following marrow harvest, patients receive up to 4 more alternating courses of PEV/VDIA; those with no response or progressive disease after the sixth chemotherapy course are referred for other therapy. Patients who complete PEV/VDIA receive 3 weeks of radiotherapy to the primary tumor bed or residual tumor. Stage 4 patients in complete or very good partial remission and with sufficient harvested marrow undergo ABMT following radiotherapy. Myeloablation consists of high-dose MIBG radioisotope therapy followed by high-dose melphalan, etoposide, and carboplatin. All other patients and those who refuse ABMT receive 1 year of alternating, low-dose chemotherapy courses, beginning concurrently with initiation of radiotherapy. One regimen consists of oral melphalan/etoposide for 5 days and the other regimen consists of intravenous vincristine on 1 day and oral cyclophosphamide for 7 days. Therapy continues for 1 year. STAGE 4S PATIENTS Patients in risk groups 4S-A and 4S-B receive no therapy. Patients in group 4S-C receive 4-8 weekly injections of doxorubicin and vincristine (AV). Patients with tumor progression may receive low-dose radiotherapy. Primary tumor resection may be delayed up to 8 months after diagnosis in these patients. Use of G-CSF is allowed but not recommended. PROJECTED ACCRUAL: Approximately 500 patients will be accrued on this multicenter study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /20 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Neuroblastoma with diagnosis based on one of the following: Histologic confirmation; Cytologic confirmation in bone marrow and elevated catecholamine metabolites; Typical tumor appearance on CT, MRI, or ultrasound and: Unequivocal MIBG uptake in tumor; Elevated catecholamines in serum or urine - No primitive neuroectodermal tumor or primary intracerebral neuroblastoma; Such patients referred to protocol GER-HIT90 --Prior/Concurrent Therapy-- - No prior cytostatic therapy (e.g., for Wilms' tumor); No concurrent therapy --Patient Characteristics-- - Age: Under 21 - Other: No serious cerebral trouble; No severe concomitant disease, e.g.: No severe congenital malformation; No severe organ function abnormality
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrankBerthold, Study Chair, University of Cologne
University of Cologne
Frechen, , DOH-5-0226
Germany
Additional Information:
Study ID Numbers: CDR0000064902; GER-NB90,EU-96004
Study Start Date: July 1990
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002802
Other Localized Unresectable Neuroblastoma Studies:
1. Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Patients With Neuroblastoma
2. Combination Chemotherapy Before Surgery in Treating Children With Localized Neuroblastoma
3. Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
4. Surgery in Treating Patients With Neuroblastoma
5. Combination Chemotherapy in Treating Children With Neuroblastoma
Related Studies:
Other localized unresectable neuroblastoma Clinical Trials
Other Clinical Trials
Other Frechen Clinical Trials
Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
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