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TLK286 in Treating Patients With Advanced Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036920
Recruitment Status : Completed
First Posted : November 21, 2003
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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 TLK286 in treating patients who have advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: canfosfamide hydrochloride Phase 2

Detailed Description:

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.

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Study Of TLK286 For The Treatment Of Advanced Non-Small Cell Lung Cancer
Study Start Date : January 2002
Actual Primary Completion Date : August 2002
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036920

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Study Chair: Mark G. Kris, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
Henner WD, Figlin RA, Garland LL, et al.: Phase 2 study of TLK286 (GST P1-1 activated glutathione analog) in advanced non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1249, 2002.

Layout table for additonal information Identifier: NCT00036920    
Other Study ID Numbers: TLK-286.2004
CDR0000069341 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: November 21, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: December 2009
Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms