|
Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors Clinical research trials and Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors. Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors  Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
For Condition: recurrent childhood rhabdomyosarcoma,previously treated childhood rhabdomyosarcoma,recurrent childhood soft tissue sarcoma,recurrent tumors of the Ewing's family
Status: Not yet recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as ecteinascidin 743 use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of ecteinascidin 743 in treating young patients who have recurrent or refractorysoft tissue sarcoma or Ewing's family of tumors.
Details: OBJECTIVES: - Determine the response rate in pediatric patients with recurrent or refractory soft tissue sarcomas or Ewing's sarcoma family of tumors treated with ecteinascidin 743. - Determine the toxicity of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma family of tumors vs rhabdomyosarcoma vs nonrhabdomyosarcomatous soft tissue sarcoma). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 30 days. PROJECTED ACCRUAL: A total of 30-60 patients (10-20 per stratum) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or refractory sarcomas, including the following: - Rhabdomyosarcoma - Nonrhabdomyosarcomatous soft tissue sarcoma - Ewing's sarcoma - Measurable disease by imaging studies - Lesions assessable only by radionuclide scans are not considered measurable - If the only measurable lesion has been previously irradiated, then that lesion must have shown evidence of an interim increase in size - No significant amount of metastatic liver disease, defined as the following: - Lesions occupying more than 25% of the liver by imaging and abnormal liver function tests or abnormal synthetic liver function PATIENT CHARACTERISTICS: Age - 21 and under (at time of diagnosis) Performance status - Lansky 50-100% (10 years of age and under) - Karnofsky 50-100% (over 10 years of age) Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (transfusion allowed) Hepatic - See Disease Characteristics - Bilirubin no greater than upper limit of normal (ULN) - Total alkaline phosphatase no greater than ULN OR - Hepatic fraction alkaline phosphatase and 5 nucleotidase no greater than ULN - SGOT and SGPT normal for age - Albumin at least 2.5 g/dL Renal - Maximum creatinine based on age as follows: - 0.8 mg/dL (5 years of age and under) - 1.0 mg/dL (6 to 10 years of age) - 1.2 mg/dL (11 to 15 years of age) - 1.5 mg/dL (over 15 years of age) OR - Creatinine clearance or radioisotope glomerular filtration rate (GFR) at least 70 mL/min Cardiovascular - No uncompensated congestive heart failure within the past 6 months Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 2 months after study participation - No active uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy - More than 1 week since prior growth factors that support platelet or white blood cell number or function - At least 7 days since prior biologic agents and recovered - No prior allogeneic stem cell transplantation - No other concurrent immunomodulating agents Chemotherapy - More than 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered - No more than 2 prior multi-agent chemotherapy regimens - No other concurrent anticancer chemotherapy Endocrine therapy - Concurrent steroids allowed Radiotherapy - See Disease Characteristics - At least 6 weeks since prior since prior extended radiotherapy and recovered - No prior total body radiotherapy - Concurrent radiotherapy to localized painful lesions allowed provided at least 1 measurable lesion is not irradiated* NOTE: *Any irradiated lesion cannot be used to assess tumor response Surgery - Not specified Other - At least 7 days since prior enzyme-inducing anticonvulsants (e.g., carbamazepine, phenobarbital, or phenytoin) - No concurrent enzyme-inducing anticonvulsants - No other concurrent investigational agents - No concurrent CYP3A4 inhibitors, including the following: - Grapefruit juice - Erythromycin - Azithromycin - Clarithromycin - Rifampin and its analogs - Fluconazole - Ketoconazole - Itraconazole - Cimetidine - Cannabinoids (marijuana or dronabinol) - Leukotriene inhibitors used in asthma (e.g., zafirlukast, montelukast, or zileuton)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SylvainBaruchel, Study Chair, Hospital for Sick Children
Additional Information:
Study ID Numbers: CDR0000329999; COG-ADVL0221
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070109
Other Recurrent Childhood Rhabdomyosarcoma Studies:
1. Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
2. Imatinib Mesylate in Treating Patients With Recurrent Ewing's Family of Tumors or Desmoplastic Small Round-Cell Tumor
3. Combination Chemotherapy, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Patients With Ewing's Sarcoma, Peripheral Primitive Neuroectodermal Tumor, or Rhabdomyosarcoma
4. Chemotherapy in Treating Children With Recurrent or Refractory Sarcomas
5. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
Related Studies:
Other recurrent childhood rhabdomyosarcoma Clinical Trials
Other Clinical Trials
Other Clinical Trials
Ecteinascidin 743 in Treating Young Patients With Recurrent or Refractory Soft Tissue Sarcoma or Ewing's Family of Tumors
|
|
|
|
|
|
|
|
