|
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer 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 Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer Clinical research trials and Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer 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 Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer. Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer 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 Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer 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.
|
|
|
|
|
|
|
Home > "F" Clinical Trials Conditions > Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer  Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
For Condition: extensive stage small cell lung cancer,Recurrent Small Cell Lung Cancer,limited stage small cell lung cancer
Status: Completed
Sponsor(s): University of Michigan Comprehensive Cancer Center , National Cancer Institute (NCI)
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 fenretinide in treating patients who have recurrent small cell lung cancer
Details: OBJECTIVES: - Determine the efficacy of fenretinide, in terms of complete and partial response rates, duration of response, and survival, in patients with recurrent small cell lung cancer. - Determine the toxicity of this regimen in these patients. - Correlate the induction of apoptosis or the expression of molecular mediators of apoptosis in tumor cells with response rates, response duration, and survival in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive oral fenretinide twice daily on days 1-7. Treatment continues every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 11-16 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) after platinum-containing chemotherapy regimen with or without thoracic radiotherapy - Limited stage or extensive stage SCLC - Measurable disease - At least 20 mm by conventional techniques OR - At least 10 mm with spiral CT scan - No pleural effusions, bone metastases, brain metastases, or abnormal radionucleotide scans as sole evidence of disease - No symptomatic or uncontrolled brain or leptomeningeal disease - Previously treated brain metastases allowed if neurologically stable PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,500/mm^3 - Platelet count at least 70,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 2 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular: - No symptomatic heart disease - No myocardial infarction within the past 6 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception for 1 month before, during, and for 2 months after study - No pre-existing retinal degenerative disease (e.g., retinitis pigmentosa or associated disorders) - No other serious concurrent illness - No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy - No more than 2 prior chemotherapy regimens Endocrine therapy: - Concurrent steroids allowed at stable dose Radiotherapy: - See Disease Characteristics - No prior radiotherapy to study lesions Surgery: - Not specified Other: - At least 3 weeks since prior systemic retinoid or carotenoid therapy - No concurrent anticonvulsants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GregoryKalemkerian, Study Chair, University of Michigan Comprehensive Cancer Center
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Additional Information:
Study ID Numbers: CDR0000068428; NCI-T99-0112,CCUM-9940
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00009971
Other Recurrent Small Cell Lung Cancer Studies:
1. Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
2. Amifostine, Chemotherapy, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
3. Tirapazamine Combined With Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
4. Neoadjuvant Chemoradiotherapy Followed By Surgery in Treating Patients With Limited-Stage Small Cell Lung Cancer
5. Cisplatin, Etoposide, and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Related Studies:
Other Recurrent Small Cell Lung Cancer Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Fenretinide in Treating Patients With Recurrent Small Cell Lung Cancer
|
|
|
|
|
|
|
|
