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Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma Clinical research trials and Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma health trials occur in a lot of of places throughout 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma. Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma clinical trial. Human subjects frequently get the finest healthcare available for their Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma  Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma
Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma
For Condition: advanced malignant mesothelioma,localized malignant mesothelioma,recurrent malignant mesothelioma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: Patient Abstract available in the near future.
Details: OBJECTIVES: I. Determine the antitumor efficacy of a liposomal-cisplatin analogue (L-NDDP) administered into the pleural space in patients with malignant pleural mesothelioma. II. Determine the time to progression and overall survival in this patient population. III. Evaluate the quantitative and qualitative toxicity of intrapleural L-NDDP. PROTOCOL OUTLINE: All patients undergo a thoracoscopy under general anesthesia. The thoracoscope is removed and any collected fluid is drained from the chest cavity. The first treatment with liposomal-cisplatin analogue (L-NDDP) is administered at this time into the intrapleural space over a 10 minute period. Subsequent 10 minute intrapleural infusions of L-NDDP through a percutaneous catheter are administered every 3 weeks. Treatment continues unless unacceptable toxic effects or disease progression occurs. Antitumor activity is assessed 2 months after the second course of therapy, and every 2 months thereafter. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Pathologically confirmed malignant pleural mesothelioma - Free flowing pleural effusion --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior biologic therapy; No concurrent immunotherapy - Chemotherapy: No prior chemotherapy; No concurrent chemotherapy - Endocrine therapy: At least 3 weeks since prior hormonal therapy; No concurrent hormonal therapy - Radiotherapy: No prior chest radiotherapy; At least 3 weeks since other prior radiotherapy; No concurrent radiotherapy - Surgery: Prior pleurodesis or chest surgery on the same side of the effusion is allowed as long as there is a free flowing pleural effusion without loculation; At least 2 weeks since major surgery other than biopsy - Other: At least 3 weeks since use of any other investigational medication; No concurrent use of any other investigational medications --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: WBC greater than 4,000/mm3; Granulocyte count greater than 1,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL; SGPT no greater than 1.5 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No unstable angina; No clinical evidence of congestive heart failure - Pulmonary: No postobstructive pneumonia - Other: Fertile patients must use effective contraception; Not pregnant or nursing; No serious concurrent infection; No prior malignancies except basal cell or squamous cell skin carcinomas, stage I colon, cervical, breast, prostate, head and neck, or lung cancer, as long as there has been no evidence of tumor occurrence within the past 5 years
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AbrahamChachoua, Study Chair, Kaplan Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Additional Information:
Study ID Numbers: CDR0000066141; NYU-9850,NCI-G99-1575,MDA-FDR001234,MDA-ID-95209
Study Start Date: September 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004033
Other Localized Malignant Mesothelioma Studies:
1. Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
2. Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
3. Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
4. Vaccine Therapy and Ganciclovir in Treating Patients With Mesothelioma
5. Surgery and Photodynamic Therapy in Treating Patients With Malignant Mesothelioma
Related Studies:
Other localized malignant mesothelioma Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase II Clinical Study of a Liposomal-Cisplatin Analogue (L-NDDP) Administered Intrapleurally in Patients with Malignant Pleural Mesothelioma
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