Clinical trial · Interventional
Irinotecan for Previously Treated, Advanced, Non-Small Cell Lung Cancer
A Pilot, Non-Randomized Phase II Protocol of Irinotecan for Patients With Previously Treated, Advanced, Non-Small Cell Lung Cancer With High ISG 15 Expression
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Inadequate enrollment (2 subjects in 4 years)
Summary
Brief summary (as posted)
Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs and other agents. There is a factor called ISG15 which might help doctors better identify patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases. Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in cell growth, and it has been FDA approved for 17 years for another type of cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan
- description
- The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.
- interventionNames
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Tumor Response
- timeFrame
- 8 weeks
- description
- Change in tumor size will be measured by CT scan using RECIST criteria.
Secondary outcomes (6)
- measure
- Time to Progression (TTP)
- timeFrame
- Up to 100 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: -INCLUSION: 18 years of age or older Have received prior chemotherapy for histologically proven advanced non-small cell lung cancer, up to 3 prior treatments Tumors display high ISG15 (ISG15H) at screening Life expectancy of at least 12 weeks ECOG/Zubrod performance status of 0-2 Provide informed consent permission to participate Adequate bone marrow function as follows: 1\. Absolute neutrophil count of greater than or equal to 1,500 or cells/mm3, and 2) Platelet count greater than or equal to 100,000/mm3 and 3) Absence of a regular red blood cell transfusion requirement Adequate hepatic function with: 1. Total bilirubin less than or equal to 4.0 mg/dl, and 2. SGOT or SGPT less than or equal to four times ULN Adequate renal function as defined by: 1\) Serum creatinine less than or equal to 1.5 x ULN Exclusion Criteria: Symptomatic brain metastases Pregnant women or nursing mothers Patients of child bearing potential must use adequate contraception. May not be receiving other concurrent chemotherapy or radiation therapy Severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections Previous hypersensitivity reaction to camptothecins
References
Publications (0)
Data not yet available