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ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen Clinical research trials and ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen. ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen clinical trial. Subjects typically recieve the finest healthcare available for their ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
For Condition: localized malignant mesothelioma,recurrent malignant mesothelioma,advanced malignant mesothelioma
Status: Recruiting
Sponsor(s): Alfacell ,
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether Onconase plus doxorubicin is more effective than doxorubicin alone in treating patients with malignant mesothelioma. PURPOSE: Randomizedphase III trial comparing Onconase plus doxorubicin with doxorubicin alone in treating patients with malignant mesothelioma.
Details: OBJECTIVES: - Compare the efficacy of doxorubicin with or without Onconase in patients with malignant pleural or peritoneal mesothelioma. - Compare the safety profile of these regimens in these patients. - Compare the overall survival, progression-free survival, and quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, controlled, multicenter study. Patients are stratified according to disease histology (epithelioid vs nonepithelioid) and CALGB groups 1-4. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive Onconase IV over 30 minutes weekly followed by doxorubicin IV. Treatment repeats every 3 weeks for at least 6 courses in the absence of disease progression. Patients demonstrating evidence of clinical response or stable disease may continue on maintenance therapy with Onconase as a single agent until disease progression. - Arm II: Patients receive doxorubicin as in arm I for up to 6 courses. Quality of life is assessed. PROJECTED ACCRUAL: A minimum of 300 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant pleural or peritoneal mesothelioma - Measurable or evaluable disease - CALGB groups 1-4 - No CNS metastases PATIENT CHARACTERISTICS: Age: - 21 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3,500/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - SGOT no greater than 2 times upper limit of normal - Bilirubin no greater than 2 mg/dL - PT and PTT normal Renal: - Creatinine normal Cardiovascular: - No symptomatic New York Heart Association class II-IV cardiovascular disease - No congestive heart failure - No angina pectoris - No cardiac arrhythmias - No uncontrolled hypertension - No cerebrovascular disease Metabolic: - No serum calcium, phosphate, electrolyte, or other metabolic abnormalities, such as metabolic acidosis Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious infection - No uncontrolled psychosis or neurologic disease (e.g., seizure disorders) - No uncontrolled diabetes mellitus - No other primary malignancy within the past 5 years except nonmelanoma skin cancer - No senility or emotional instability PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No more than one prior systemic chemotherapy regimen - No prior doxorubicin - At least 6 weeks since prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - Prior radiotherapy for progressive or recurrent disease allowed except myocardium radiotherapy Surgery: - Prior surgical resection allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DianeScudiery, Study Chair, Alfacell
Lungenklinik Heckeshorn *Recruiting*
Berlin, , 14109
Germany
Recruiting R. Loddenkemper 49-30-8002-2329
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Robert Taub 212-305-4076
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora, Colorado, 80010
United States
Recruiting Karen Kelly 303-315-8801
Asklepios Fachkliniken Munchen - Gauting *Recruiting*
Gauting, , DOH-82131
Germany
Recruiting Joachim Pawel 49-89-8579-12011
Center for Cancer Care *Recruiting*
Charlottesville, Virginia, 22902
United States
Recruiting Stefan Gorsch 434-982-8410
Oncology-Hematology Group of South Florida *Recruiting*
Miami, Florida, 33176
United States
Recruiting Paul Kaywin 305-595-2141
Hospital Grosshansdorf *Recruiting*
Grosshansdorf, , D-22927
Germany
Recruiting Ulrich Gatzemeier 49-41-02-601-188
Klinikum Rechts Der Isar - Technische Universitaet Muenchen *Recruiting*
Munich, , D-81675
Germany
Recruiting Christian Peschel 49-89-4140-4111
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Jose Bufill 574-284-7370
Lone Star Oncology *Recruiting*
Austin, Texas, 78759
United States
Recruiting John Costanzi 512-343-2103
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Nicholas Vogelzang 773-702-6743
Sharp Rees-Stealy Medical Group *Recruiting*
San Diego, California, 92123-2762
United States
Recruiting Dana Glenn 858-541-6622
Tower Hematology Oncology Medical Group *Recruiting*
Los Angeles, California, 90048
United States
Recruiting Solomon Hamburg 310-289-2840
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Ralph Zinner 713-792-6363
Allgemeines Krankenhaus *Recruiting*
Hamburg, , DOH-21075
Germany
Recruiting Eckhard Kaukel 49 40 79212241
Somerset Medical Center *Recruiting*
Somerville, New Jersey, 08876
United States
Recruiting Hen-Vai Wu 908-685-2481
Additional Information:
Study ID Numbers: CDR0000065639; ALFACELL-P30-302,NCI-V97-1273
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003034
Other Recurrent Malignant Mesothelioma Studies:
1. ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
2. Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
3. Radiation Therapy in Preventing Metastatic Cancer in Patients Who Have Diagnostic Procedures to Identify Malignant Mesothelioma
4. Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Peritoneal Cancer
5. Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
Related Studies:
Other recurrent malignant mesothelioma Clinical Trials
Other California Clinical Trials
Other San Diego Clinical Trials
ONCONASE Plus Doxorubicin Versus Doxorubicin Alone For Patients With Malignant Pleural or Peritoneal Mesothelioma Who Have Had No More Than One Prior Chemotherapy Regimen
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