|
Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor 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 Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor Clinical research trials and Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor 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 Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor. Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor 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 Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor clinical trial. Human subjects often receive the most effective healthcare possible for their Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor 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 > Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor  Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
For Condition: Ewing's family of tumors,childhood soft tissue sarcoma
Status: 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 patients who have relapsed or refractoryEwing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.
Details: OBJECTIVES: - Determine the objective response rate in patients with Ewing's sarcoma, primitive neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan mesylate. - Determine the time to tumor progression in patients treated with this drug. - Determine median survival and 6- and 12-month survival of patients treated with this drug. - Determine the pain response in patients treated with this drug. - Determine the qualitative and quantitative toxic effects of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified according to disease (relapsed or refractory localized or metastatic Ewing's sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor). Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses, or 6 courses beyond maximal response (whichever is longer). Patients are followed every 3 months for 1 year after withdrawal from study. PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for stratum I within 12 months. A total of 9-17 patients will be accrued for stratum II within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following histologically confirmed diagnoses: - Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor - Desmoplastic small round cell tumor - 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 of age) - Lansky 60-100% (10 years of age 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 - AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) - Albumin at least 2.8 g/dL Renal - Creatinine less than 1.5 times ULN Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active serious infection - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No overt psychosis or mental disability that would preclude informed consent - No other life-threatening illness within the past 6 months PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior autologous bone marrow or stem cell transplantation - No concurrent biologic therapy Chemotherapy - Recovered from prior systemic chemotherapy - Prior topoisomerase I inhibitor therapy allowed - No other concurrent chemotherapy Endocrine therapy - Not specified Radiotherapy - More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy - More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve - No concurrent radiotherapy Surgery - At least 4 weeks since prior major surgery and recovered - No concurrent surgery Other - More than 28 days since prior investigational drugs (including analgesics or antiemetics) - No more than 2 prior treatment regimens for this disease - No other investigational drugs during and for 28 days after study therapy - No other concurrent anticancer therapy - No concurrent grapefruit or grapefruit juice
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertDeJager, Study Chair, Daiichi Pharmaceuticals
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Richard Drachtman 732-235-7898
Nemours Children's Clinic *Recruiting*
Jacksonville, Florida, 32207
United States
Recruiting Eric Sandler 904-390-3793
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80218
United States
Recruiting Lia Gore 303-315-8251
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Cynthia Herzog 713-792-6620
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Tanya Trippett 212-639-8267
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Sylvain Baruchel 416-813-7795
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Victor Aquino 214-648-3074
Medical City Dallas Hospital *Recruiting*
Dallas, Texas, 75230
United States
Recruiting Joel Weinthal 972-566-6647
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105
United States
Recruiting Carlos Rodriguez-Galindo 901-495-2203
Additional Information:
Study ID Numbers: CDR0000271889; SJCRH-DXEWS,DAIICHI-8951A-PRT034
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055952
Other Childhood Soft Tissue Sarcoma Studies:
1. Irinotecan in Treating Children With Refractory Solid Tumors
2. Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma
3. Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
4. Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
5. Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
Related Studies:
Other childhood soft tissue sarcoma Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
|
|
|
|
|
|
|
|
