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

NCT00036920 | Completed Phase 2

• 4 other identifiers: TLK-286.2004MSKCC-01147CDR0000069341NCI-G02-2063
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Interventions

canfosfamide hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

TER 286

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mark G. Kris, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 13, 2002
• First Posted: November 21, 2003
• Study Start: January 1, 2002
• Primary Completion: August 1, 2002
• Study Completion: December 1, 2009
• Last Updated: June 26, 2013

Record last verified: 2009-12

Locations

US (1)