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Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma Clinical research trials and Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma healthcare trials take place in a lot of 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 assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma. Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma clinical trial. Human subjects often obtain the finest healthcare possible for their Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma  Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
For Condition: recurrent adult soft tissue sarcoma,stage 4A adult soft tissue sarcoma,stage 3 adult soft tissue sarcoma,stage 4B adult soft tissue sarcoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
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 ecteinascidin 743 in treating patients who have unresectable advanced or metastatic soft tissue sarcoma.
Details: OBJECTIVES: I. Determine the rate of clinical benefit, in terms of the incidence of objective partial and complete response, stable disease, or minor response of more than 3 months duration, in patients with previously treated, unresectable advanced or metastatic soft tissue sarcoma treated with ecteinascidin 743. II. Determine the progression-free survival, overall survival, and response duration in patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Determine the pharmacokinetic-pharmacodynamic relationship of this drug in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients are stratified according to number of prior cytotoxic therapies for advanced disease (1-2 vs more than 2). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 36-76 patients (18-38 per stratum) will be accrued for this study within 13 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced or metastatic soft tissue sarcoma; Unresectable disease - Previously treated with at least 1 prior non-adjuvant chemotherapy regimen for advanced or metastatic disease; Adjuvant chemotherapy considered first-line treatment for advanced disease if the first relapse is less than 6 months after completion of therapy - At least 1 bidimensionally measurable non-irradiated lesion; At least 20 mm in at least 1 diameter by CT scan; At least 20 by 20 mm for clinically measurable lesion - No gastrointestinal stromal sarcoma - No HIV-related Kaposi's sarcoma - No malignant mesothelioma - No chondrosarcomas - No symptomatic brain or leptomeningeal involvement --Prior/Concurrent Therapy-- - Biologic therapy: Recovered from prior immunotherapy; No concurrent prophylactic colony-stimulating factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF)) during first course of study; No concurrent anticancer immunotherapy - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered; No other concurrent chemotherapy - Endocrine therapy: No concurrent anticancer hormonal therapy - Radiotherapy: See Disease Characteristics; Recovered from radiotherapy; No concurrent radiotherapy except palliative local radiotherapy - Surgery: See Disease Characteristics - Other: At least 30 days since prior investigational drugs; No other concurrent investigational or experimental anticancer drugs; No concurrent participation in other clinical trial --Patient Characteristics-- - Age: 18 and over - Performance status: WHO 0-2 OR Karnofsky 60-100% - Life expectancy: At least 3 months Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); Alkaline phosphatase no greater than ULN (unless suspected bone metastases present); AST/ALT less than 2.5 times ULN; Albumin at least 2.5 g/dL; No chronic active liver disease - Renal: Creatinine no greater than 1.8 mg/dL OR Creatinine clearance at least 40 mL/min - Cardiovascular: No congestive heart failure; No angina pectoris, even if medically controlled; No myocardial infarction within the past year; No uncontrolled arterial hypertension or arrhythmias - Other: No other neoplastic disease within the past 5 years except non-melanoma skin cancer or carcinoma in situ; No other serious illness or medical condition; No active infection; No history of significant neurological or psychiatric disorders; No symptomatic peripheral neuropathy grade 2 or greater; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 1 month after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMaki, Study Chair, Memorial Sloan-Kettering Cancer Center
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068643; NCI-G01-1948,MSKCC-01018,PMAR-ET-B-022-00
Study Start Date: February 2001
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017030
Other Stage 3 Adult Soft Tissue Sarcoma Studies:
1. Chemotherapy, SU5416, Radiation Therapy, and Surgery in Treating Patients With Soft Tissue Sarcoma
2. Combination Chemotherapy in Treating Patients With Soft Tissue Sarcoma
3. Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
4. Antineoplaston Therapy in Treating Patients With Soft Tissue Sarcoma
5. Perifosine in Treating Patients With Advanced Soft Tissue Sarcoma
Related Studies:
Other stage 3 adult soft tissue sarcoma Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Ecteinascidin 743 in Treating Patients With Unresectable Advanced or Metastatic Soft Tissue Sarcoma
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