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Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma Clinical research trials and Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma. Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma clinical trial. Participants frequently obtain the most expert healthcare available for their Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma  Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma
Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma
For Condition: untreated childhood medulloblastoma
Status: Recruiting
Sponsor(s): Children's Hospital of Philadelphia ,
Synopsis: RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Combining low-dose radiation therapy with combination chemotherapy may be effective in treating primitive neuroectodermal tumor and medulloblastoma. PURPOSE: Phase II trial to study the effectiveness of combining low-dose radiation therapy with combination chemotherapy after surgery in treating children who have newly diagnosed primitive neuroectodermal tumor or medulloblastoma.
Details: OBJECTIVES: - Reduce the late cognitive, auditory, and endocrinologic effects in children with newly diagnosed standard-risk posterior fossa primitive neuroectodermal tumor or medulloblastoma by reducing the adjuvant craniospinal radiotherapy dose by 25%, but maintaining a therapeutic efficacy (86% 3-year relapse-free survival) of current standard therapy by using maintenance chemotherapy comprising lomustine, cisplatin, and vincristine alternated with cyclophosphamide and etoposide. - Evaluate the acute and subacute toxicity of this regimen in these patients. - Evaluate the late neurotoxic effects of low-dose craniospinal radiotherapy, in terms of cognitive, endocrinologic, and auditory function, in these patients. OUTLINE: This is a multicenter study. - Adjuvant induction chemoradiotherapy: Beginning within 21 days after prior resection, patients undergo radiotherapy to the craniospinal axis 5 days a week for 2 weeks and then conformal radiotherapy to the tumor bed 5 days a week for 4 weeks. Beginning 1 week after the initiation of radiotherapy, patients receive vincristine IV weekly for 6 weeks. - Beginning 4 weeks after the completion of induction chemoradiotherapy, patients receive two 6-week courses of regimen A as outlined below alternated with one 6-week course of regimen B as outlined below for a total of 9 courses (6 courses of regimen A and 3 courses of regimen B). - Regimen A: Patients receive oral lomustine and cisplatin IV over 8 hours on day 0 and vincristine IV on days 0, 7, and 14. - Regimen B: Patients receive cyclophosphamide IV on days 0 and 1 and etoposide IV on days 0 and 1 and then orally on days 14-34. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/30 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed posterior fossa primitive neuroectodermal tumor or medulloblastoma - Standard-risk disease - No residual tumor greater than 1.5 cm^2 after resection by postoperative MRI - No tumor in the spinal or cerebral subarachnoid space by MRI - No tumor in the subarachnoid space by CSF cytology - No failure to perform staging studies (spine MRI and CSF cytology) preoperatively or postoperatively - Must begin radiotherapy on study within 28 days after surgery PATIENT CHARACTERISTICS: Age: - 3 to 30 at initial diagnosis Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Not specified Renal: - Not specified Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior antitumor chemotherapy Endocrine therapy: - Prior corticosteroids allowed Radiotherapy: - See Disease Characteristics - No prior radiotherapy Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterPhillips, Study Chair, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Anna Janss 215-590-2800
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Paul Fisher 650-497-8000
Additional Information:
Study ID Numbers: CDR0000069075; CHP-IRB-2001-12-2301,CHP-693,NCI-V01-1680
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00031590
Other Untreated Childhood Medulloblastoma Studies:
1. Combination Chemotherapy in Treating Children With Astrocytomas and Primitive Neuroectodermal Tumors
2. Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma
3. Genetic Study of Newly Diagnosed Central Nervous System Tumors in Young Children
4. Gene Testing to Help in the Diagnosis and Treatment of Childhood Brain Tumors
5. Radiation Therapy Plus Combination Chemotherapy in Treating Children With Medulloblastoma
Related Studies:
Other untreated childhood medulloblastoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Low-Dose Radiation Therapy and Combination Chemotherapy Following Surgery in Treating Children With Newly Diagnosed Primitive Neuroectodermal Tumor or Medulloblastoma
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