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Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer Clinical research trials and Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer. Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer  Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
For Condition: recurrent non-small cell lung cancer,stage 4 non-small cell lung cancer,squamous cell lung cancer,stage 3B non-small cell lung cancer,bronchoalveolar cell lung cancer,large cell lung cancer,adenocarcinoma of the lung,adenosquamous cell lung cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: Patient Abstract available in the near future.
Details: OBJECTIVES: I. Determine the 12-month survival of patients with advanced non-small cell lung cancer treated with TLK286. II. Determine the overall survival of patients treated with this drug. III. Determine the objective response rate, duration of objective response, time to tumor progression, and disease stabilization in patients treated with this drug. IV. Determine the safety of this drug in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter. PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study within 12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed non-small cell lung cancer (NSCLC), including: Squamous cell carcinoma; Undifferentiated carcinoma; Adenocarcinoma; Mixed (i.e., adenocarcinoma with squamous cell carcinoma); No mixed tumors containing small cell lung carcinoma elements; Bronchoalveolar carcinoma; Large cell carcinoma - Bronchoalveolar lavage allowed for diagnosis - Advanced or metastatic NSCLC Stage IIIB disease ineligible for combined chemotherapy and radiotherapy OR Stage IV disease - Progressive NSCLC during or after first-line therapies with platinum-containing chemotherapy regimens in the advanced or metastatic setting - Measurable disease by radiological imaging techniques - Previously treated CNS metastases allowed provided: Neurologically stable; Oral or IV steroids or anticonvulsants not required; No active disease by CT scan or MRI - No known leptomeningeal metastases or carcinomatous meningitis --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy; At least 2 weeks since prior filgrastim (G-CSF) or sargramostim (GM-CSF); No concurrent immunotherapy; No concurrent biological response modifiers - Chemotherapy: See Disease Characteristics; No more than 2 prior cytotoxic regimens in the advanced or metastatic setting; At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin); No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics - Radiotherapy: At least 4 weeks since prior radiotherapy; At least 4 weeks since prior radiopharmaceuticals; At least 2 weeks since prior palliative radiotherapy; No concurrent radiotherapy except local radiotherapy for pain or solitary brain metastasis if not progressing systemically - Surgery: At least 4 weeks since prior major surgery - Other: Recovered from prior therapy; Prior adjuvant therapy allowed; At least 30 days since prior investigational drugs; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-1 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin no greater than 2.0 mg/dL; ALT and AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present) - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min; No gross hematuria - Cardiovascular: No uncontrolled cardiac arrhythmia; No myocardial infarction within the past 6 months - Other: No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer; No severe concurrent disease, infection, or comorbidity that would preclude study; No other unstable medical conditions; No psychiatric disorders that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 6 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkKris, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000069341; NCI-G02-2063,TLK-286.2004,MSKCC-01147
Study Start Date: January 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036920
Other Squamous Cell Lung Cancer Studies:
1. Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer
2. Chemotherapy and Radiation Therapy With or Without Efaproxiral in Treating Patients With Stage III Non-Small Cell Lung Cancer
3. Carboplatin, Paclitaxel, and Radiation Therapy With or Without Thalidomide in Treating Patients With Stage III Non-small Cell Lung Cancer
4. Lonafarnib and Gemcitabine in Treating Patients With Advanced Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
5. Gemcitabine and Docetaxel in Treating Patients With Inoperable Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
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