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Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma Clinical research trials and Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma. Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma clinical trial. Test subjects typically obtain the finest healthcare available for their Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma  Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
For Condition: recurrent childhood rhabdomyosarcoma,previously treated childhood rhabdomyosarcoma
Status: No longer recruiting
Sponsor(s): Daiichi Pharmaceuticals ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating children who have relapsed or refractoryrhabdomyosarcoma.
Details: OBJECTIVES: - Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate. - Determine the time to tumor progression in patients treated with this drug. - Determine the median survival and survival at 6 and 12 months in patients treated with this drug. - Assess pain in patients treated with this drug. - Evaluate the quantitative and qualitative toxic effects of this drug in these patients. - Evaluate the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, multicenter study. Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed recurrent or resistant rhabdomyosarcoma - Measurable disease - The following are not considered measurable disease: - Ascites - Pleural effusion - Lytic bone lesions - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - Any age Performance status - ECOG 0-2 (over 10 years old) - Lansky 60-100% (10 years old and under) Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 750/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 8.5 g/dL Hepatic - Bilirubin no greater than 2.0 mg/dL - Albumin at least 2.8 g/dL - AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present) Renal - Creatinine no greater than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No life threatening illness (unrelated to tumor) within the past 6 months - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No concurrent active serious infection - No concurrent uncontrolled infection - No overt psychosis or other incompetency that would preclude study compliance or giving informed consent - No other concurrent noncancer-related illness that would preclude study participation or follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior autologous bone marrow or stem cell transplantation - No concurrent anticancer biologic therapy Chemotherapy - Recovered from prior adjuvant or systemic chemotherapy - Prior topoisomerase I inhibitor therapy allowed - No other concurrent anticancer chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis, whole pelvis, or 25% of marrow reserve - No concurrent anticancer radiotherapy Surgery - At least 4 weeks since prior major surgery - Recovered from prior surgery - No concurrent anticancer surgery Other - At least 28 days since prior investigational drugs (including analgesics or antiemetics) - No more than 2 prior regimens for rhabdomyosarcoma - No concurrent grapefruit-containing beverages or foods - No other concurrent investigational drugs during and for 28 days after final dose of study drug
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
United States
Nemours Children's Clinic
Jacksonville, Florida, 32207
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
United States
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390-9063
United States
Medical City Dallas Hospital
Dallas, Texas, 75230
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, 80218
United States
Additional Information:
Study ID Numbers: CDR0000271888; DAIICHI-8951A-PRT033,SJCRH-DXRMS
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055939
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. Comparison of Chemotherapy Regimens in Treating Children With Relapsed or Progressive Rhabdomyosarcoma
3. Health-Related Outcomes in Patients Who Were Previously Treated for Rhabdomyosarcoma
4. Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
5. Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Metastatic Ewing's Sarcoma or Rhabdomyosarcoma That Has Spread to the Bone
Related Studies:
Other recurrent childhood rhabdomyosarcoma Clinical Trials
Other New Jersey Clinical Trials
Other New Brunswick Clinical Trials
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
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