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Combination Chemotherapy or Observation Following Surgery in Treating Infants 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 Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma Clinical research trials and Combination Chemotherapy or Observation Following Surgery in Treating Infants 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 Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma. Combination Chemotherapy or Observation Following Surgery in Treating Infants 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 Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma clinical trial. Human subjects often get the best healthcare possible for their Combination Chemotherapy or Observation Following Surgery in Treating Infants 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 > "C" Clinical Trials Conditions > Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma  Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma
Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma
For Condition: stage 4S neuroblastoma,regional neuroblastoma,localized unresectable neuroblastoma,localized resectable neuroblastoma
Status: No longer recruiting
Sponsor(s): University of Cologne ,
Synopsis: RATIONALE: Sometimes neuroblastoma will regress without treatment, but sometimes additional treatment may be necessary. Giving more than one chemotherapy drug after surgery to remove the tumor may kill more tumor cells. PURPOSE: Phase II trial to study combination chemotherapy or observation following surgery in treating infants with neuroblastoma.
Details: OBJECTIVES: I. Determine the incidence of spontaneous regression of localized neuroblastoma in infants. II. Determine how many infants with neuroblastoma do not need chemotherapy. III. Evaluate the time course of regression by radiologic criteria and catecholamine metabolites. IV. Determine the reliability of risk estimation by molecular characteristics (N-myc amplification, CD44, del 1p) compared to clinical criteria. V. Evaluate whether reduced therapeutic toxicity results in a decrease in treatment-related deaths. VI. Correlate cytostatic drug levels with chemotherapy side effects. PROTOCOL OUTLINE: All patients undergo resection of the primary tumor and N-myc determination within 6 months of age, unless critically ill, then are treated according to risk. Patients with amplified N-myc or with indeterminate N-myc amplification but with other risk features are treated per protocol GER-NB90. Stage 4S patients who are critically ill or thrombocytopenic receive doxorubicin, vincristine, and cyclophosphamide over 7 days. Patients with no amplification of N-myc are observed for 6 months (until between 12 and 18 months of age). Patients with minimal residual disease (less than 10% or diameter no greater than 2-5 mm) continue observation, while those with residual disease but no disease progression undergo repeat biopsy. Patients whose biopsy indicates tumor regression also continue observation. All other patients, including those with disease progression, are treated per protocol GER-NB90. PROJECTED ACCRUAL: 36-44 patients per year will be accrued (22-27 patients with stages 1-3, 8-10 patients with stage 4S, and 6-7 patients with stage 4 neuroblastoma).
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /1 Year
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: - Histologically diagnosed neuroblastoma Stages 1, 2, 3, and 4S - Resection within 6 months of diagnosis for N-myc determination - Patient age less than 1 year at diagnosis
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: CDR0000064903; GER-NB95-S,EU-96003
Study Start Date: July 1995
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002803
Other Regional Neuroblastoma Studies:
1. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
2. Multiple Therapies in Treating Patients With Advanced Neuroblastoma
3. Chemotherapy and Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
4. Combination Chemotherapy in Treating Children With Neuroblastoma
5. Therapy Based on Stage of Disease and Risk Assessment in Treating Children With Neuroblastoma
Related Studies:
Other regional neuroblastoma Clinical Trials
Other Clinical Trials
Other Frechen Clinical Trials
Combination Chemotherapy or Observation Following Surgery in Treating Infants With Neuroblastoma
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