A Phase I/II Study of Recombinant Desulfato Hirudin, Lepirudin (Refludan) in Small Cell Lung Cancer Patients Previously Treated With Chemotherapy
lepirudin
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Lung Diseases
Treatment Study
Summary
Study start date: November 1, 1998
Actual date on which the first participant was enrolled.OBJECTIVES: I. Determine the dose, safety, and antitumor response rate of lepirudin in patients with recurrent or extensive stage small cell lung cancer previously treated with chemotherapy. OUTLINE: This is a dose escalation (in individual patients) study. Patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days. Dose escalation continues in each patient until aPTT prolongation occurs or the maximum dose level is reached. The patient then continues treatment on the maximum tolerated dose. Treatment continues in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study within 18-24 months.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1 patient to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Pathologically confirmed recurrent or extensive stage small cell lung cancer. Received at least one prior chemotherapy regimen Measurable or evaluable disease that has not been irradiated No pleural effusions, bone metastases, brain metastases, elevated serum enzymes, or radionuclide scans as the sole indicator lesion Brain metastases allowed if patients received cranial irradiation and have no clinical evidence of brain metastases PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL PT and aPTT normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No unstable heart rhythm No unstable angina No clinical evidence of congestive heart failure No prior cerebrovascular accident or stroke No uncontrolled or severe hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception At least 6 weeks since any signs or symptoms of bleeding No history of bleeding disorder No bacterial endocarditis or other active infection PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: At least 6 weeks since major surgery, trauma, or needle biopsy of any organ Other: No concurrent anticoagulant or platelet inhibitor therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location