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Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma Clinical research trials and Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma. Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma clinical trial. Human subjects often get the best healthcare available for their Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma  Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
For Condition: childhood rhabdomyosarcoma,childhood soft tissue sarcoma,Muscle Cancer
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan and carboplatin as upfront window therapy (first-line therapy) in treating patients who have newly diagnosed intermediate-risk or high-riskrhabdomyosarcoma.
Details: OBJECTIVES: Primary - Determine the response rate in patients with newly diagnosed intermediate- or high-risk rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and carboplatin. - Determine the acute toxic effects of this regimen combined with radiotherapy in these patients. - Determine the safety and feasibility of this regimen in these patients. - Determine the rate of local control achieved in patients treated with this regimen in combination with intensity-modulated radiotherapy. - Determine the safety and feasibility of administering maintenance therapy comprising irinotecan to patients with high-risk rhabdomyosarcoma treated with this regimen. Secondary - Correlate, preliminarily, in vitro measurements of angiogenesis with clinical features (extent of disease), response to therapy, and outcome in patients treated with this regimen. - Determine, preliminarily, the efficacy of this regimen, in terms of improved outcomes, in these patients. OUTLINE: This is a pilot study. - Courses 1 and 2: Patients receive carboplatin IV over 1 hour on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 2 courses. - Patients receive vincristine IV on days 1, 8, and 15; dexrazoxane IV over 15-30 minutes, doxorubicin IV over 15-30 minutes, and cyclophosphamide IV over 1 hour on days 1 and 2; and filgrastim (G-CSF) subcutaneously (SC) once daily beginning on approximately day 3 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 3 courses. Some patients may undergo surgical resection of the tumor after completion of course 5. After course 5, patients undergo radiotherapy once daily, 5 days a week, for 4-5.5 weeks. - Patients receive vincristine IV and carboplatin IV over 1 hour on day 1; irinotecan IV over 1 hour on days 1-5 and 8-12; and G-CSF SC once daily beginning on approximately day 13 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses. NOTE: *Patients who develop disease progression during courses 1 or 2 do not receive further irinotecan and carboplatin. Instead, patients receive ifosfamide and etoposide as in courses 8 and 9. - Courses 8 and 9: Patients receive vincristine IV on day 1; etoposide IV over 1 hour and ifosfamide IV over 2 hours on days 1-5; and G-CSF SC once daily beginning on approximately day 6 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses. - Course 10: Patients receive vincristine IV on days 1, 8, 15, 22, 29, 36, and 43; dexrazoxane IV over 15-30 minutes, doxorubicin IV over 15-30 minutes, and cyclophosphamide IV over 1 hour on days 1 and 2; and filgrastim SC beginning on approximately day 3 and continuing until blood counts recover (1 course). - Patients receive etoposide IV over 1 hour and ifosfamide IV over 2 hours on days 1-5 and G-CSF SC once daily beginning on approximately day 6 and continuing until blood counts recover. Treatment repeats every 21 days for a total of 2 courses. Patients with high-risk disease proceed to maintenance therapy. - Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 6 courses. NOTE: *Patients who develop disease progression during courses 1 or 2 do not receive further irinotecan. In all courses, treatment continues in the absence of unacceptable toxicity or disease progression or recurrence after initial response. Patients are followed monthly for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 24-61 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /30 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed rhabdomyosarcoma (RMS), undifferentiated sarcoma, or ectomesenchymoma, meeting criteria for 1 of the following: - High-risk disease - Alveolar RMS OR ectomesenchymoma with alveolar features OR undifferentiated sarcoma AND distant metastases (stage 4, group IV) - Under 1 year of age OR at least 10 years of age with distant metastases AND one of the following diagnoses: - Embryonal RMS - Ectomesenchymoma with embryonal features - Intermediate-risk disease - Nonmetastatic undifferentiated sarcoma OR alveolar RMS OR ectomesenchymoma with alveolar features (regardless of age, site, size, stage, or degree of initial surgical resection) - Under 1 year of age with nonmetastatic embryonal RMS OR ectomesenchymoma with embryonal features (regardless of age, site, size, stage, or degree of initial surgical resection) - One year of age and over with stage 2 or 3, group III embryonal RMS OR ectomesenchymoma with embryonal features - Newly diagnosed - Previously untreated - Biopsy or definitive surgery required within the past 42 days PATIENT CHARACTERISTICS: Age - 30 and under at diagnosis Performance status - Not specified Life expectancy - Not specified Hematopoietic - Absolute neutrophil count 1,500/mm^3* - Hemoglobin 9 g/dL* - Platelet count 100,000/mm^3* NOTE: *Unless there is bone marrow infiltration by tumor or presence of disseminated intravascular coagulation Hepatic - Bilirubin < 2.5 times upper limit of normal (ULN)* - SGOT and SGPT < 2.5 times ULN* NOTE: *Unless there is hepatic involvement by tumor Renal - Creatinine normal for age OR - Creatinine clearance or nuclear glomerular filtration rate at least 80 mL/min (in the absence of obstructive hydronephrosis) Cardiovascular - Shortening fraction 28% by echocardiogram OR - LVEF 50% by MUGA Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy Endocrine therapy - Prior steroids allowed Radiotherapy - No prior radiotherapy, except limited, emergent radiotherapy (e.g., treatment of threatened airway or spinal cord compromise) Surgery - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeonardWexler, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Leonard Wexler 212-639-7990
Additional Information:
Study ID Numbers: CDR0000350083; MSKCC-03099
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00077285
Other Childhood Soft Tissue Sarcoma Studies:
1. Rebeccamycin Analogue in Treating Children With Solid Tumors or Non-Hodgkin's Lymphoma
2. Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma
3. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
4. Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
5. Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
Related Studies:
Other childhood soft tissue sarcoma Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Irinotecan and Carboplatin as Upfront Window Therapy in Treating Patients With Newly Diagnosed Intermediate-Risk or High-Risk Rhabdomyosarcoma
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