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Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer conditions. Clinical Trials Search.org is a site devoted 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 take place in many of places throughout 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like 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 allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated 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. Test subjects typically obtain 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, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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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 Recurrent Non-Small Cell Lung Cancer Studies:
1. Chemotherapy Followed by Surgery or Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
2. Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer
3. Carboplatin, Paclitaxel, and Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
4. Photodynamic Therapy With HPPH in Treating Patients With Early Stage Lung Cancer
5. Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery
Related Studies:
Other recurrent non-small cell lung cancer Clinical Trials
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Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
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