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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01531 | Registry Identifier | NCI CTRP |
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Inadequate enrollment (2 subjects in 4 years)
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| Name | Class |
|---|---|
| University of New Mexico Cancer Center | OTHER |
| Lovelace Respiratory Research Institute | UNKNOWN |
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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.
The goal of this trial is to demonstrate the potential clinical benefit of targeted irinotecan chemotherapy in NSCLC patients whose tumors display a specific phenotype that is associated with increased sensitivity to this drug, ISG15H.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Irinotecan | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Irinotecan | Drug | 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor Response | Change in tumor size will be measured by CT scan using RECIST criteria. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | Time to progression will be measured from the time of first treatment until there is evidence of progressive disease or death, from the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 100 months. Death will be treated as a progression event. | Up to 100 months |
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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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Martin J Edelman, MD | UNM Cancer Center | Principal Investigator |
| Mathewos Tessema, PhD | Lovelace Respiratory Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Oncology Associates | Albuquerque | New Mexico | 87106 | United States | ||
| University of New Mexico Cancer Center |
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| Label | URL |
|---|---|
| University of New Mexico Cancer Center, an NCI Designated Cancer Center | View source |
| New Mexico Cancer Care Alliance | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Irinotecan | 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. Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Irinotecan | 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. Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor Response | Change in tumor size will be measured by CT scan using RECIST criteria. | Both participants experienced an increase in tumor size between the time of the baseline CT scan and the first study CT scan. There will be no publication or further data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution. | Posted | Count of Participants | Participants | 8 weeks |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Irinotecan | 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. Irinotecan: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Hepatobiliary disorders | MedDRA (Unspecified) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White blood cell decreased | Blood and lymphatic system disorders | MedDRA (Unspecified) |
Early termination leading to no subjects analyzed. There will be no publication, as the original PI has left employment with the institution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Valerie Parks, RN | University of New Mexico Comprehensive Cancer Center | 505-925-0390 | vparks@salud.unm.edu |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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|
|
| Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy | Patients who have a loss of SULF2 gene expression have a better outcome than those whose tumors express SULF2. High level of ISG15 expression in NSCLC may indicate a subgroup of tumors that may be more sensitive to the cytotoxic effects of irinotecan. In patients who consent to screening, 10 unstained slides of archived diagnostic tissue will be obtained from formalin-fixed, paraffin-embedded specimens and analyzed in the laboratories of our Lovelace Respiratory Research Institute co-investigators. | 1 year |
| Toxicity of Irinotecan Salvage Chemotherapy | Use blood samples to measure possible 1) Neutropenia, 2) Thrombocytopenia, 3)Diarrhea; 4) Other measures of toxicity other than alopecia, anorexia, and asthenia as listed in the National Cancer Institute Common Toxicity Criteria v. 4.03 | 2 days preceding each cycle of therapy |
| Progression Free Survival (PFS) | Up to 100 months |
| Median Duration of Response | Up to 100 months |
| Median Overall Survival (OS) | 100 months |
| Albuquerque |
| New Mexico |
| 87131 |
| United States |
| New Mexico Cancer Care Associates | Santa Fe | New Mexico | 87505 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Progression (TTP) | Time to progression will be measured from the time of first treatment until there is evidence of progressive disease or death, from the date of first documented progression or date of death from any cause, whichever occurs first, assessed up to 100 months. Death will be treated as a progression event. | No data were collected on this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution. | Posted | Up to 100 months |
|
|
| Secondary | Retrospectively Evaluate the Role of Tumor SULF2 Gene Methylation Status in Treatment Efficacy | Patients who have a loss of SULF2 gene expression have a better outcome than those whose tumors express SULF2. High level of ISG15 expression in NSCLC may indicate a subgroup of tumors that may be more sensitive to the cytotoxic effects of irinotecan. In patients who consent to screening, 10 unstained slides of archived diagnostic tissue will be obtained from formalin-fixed, paraffin-embedded specimens and analyzed in the laboratories of our Lovelace Respiratory Research Institute co-investigators. | No data was collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution. | Posted | 1 year |
|
|
| Secondary | Toxicity of Irinotecan Salvage Chemotherapy | Use blood samples to measure possible 1) Neutropenia, 2) Thrombocytopenia, 3)Diarrhea; 4) Other measures of toxicity other than alopecia, anorexia, and asthenia as listed in the National Cancer Institute Common Toxicity Criteria v. 4.03 | There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution. | Posted | 2 days preceding each cycle of therapy |
|
|
| Secondary | Progression Free Survival (PFS) | No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution. | Posted | Up to 100 months |
|
|
| Secondary | Median Duration of Response | No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution. | Posted | Up to 100 months |
|
|
| Secondary | Median Overall Survival (OS) | No data were collected for this outcome measure. There will be no publication or data analysis, as the study was terminated early due to low enrollment (2) and the original PI has left employment with the institution. | Posted | 100 months |
|
|
| 2 |
| 2 |
| 2 |
| 2 |
| Aspartate aminotransferase increased | Hepatobiliary disorders | NCI v4.01 |
|
| Hypotension | Vascular disorders | MedDRA (Unspecified) |
|
| Pericardial effusion | Cardiac disorders | MedDRA (Unspecified) |
|
| Pericardial tamponade | Cardiac disorders | MedDRA (Unspecified) |
|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Alopecia | General disorders | MedDRA (Unspecified) |
|
| Abdominal pain | Gastrointestinal disorders | NCI v4.01 |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | MedDRA (Unspecified) |
|
| Alanine aminotransferase increased | Hepatobiliary disorders | MedDRA (Unspecified) |
|
| Alkaline phosphatase increased | Hepatobiliary disorders | MedDRA (Unspecified) |
|
| Anemia | Blood and lymphatic system disorders | MedDRA (Unspecified) |
|
| Anorexia | General disorders | MedDRA (Unspecified) |
|
| Aspartate aminotransferase increased | Hepatobiliary disorders | MedDRA (Unspecified) |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Creatinine increased | Renal and urinary disorders | MedDRA (Unspecified) |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) |
|
| Hyperglycemia | Endocrine disorders | MedDRA (Unspecified) |
|
| Hypoalbuminemia | General disorders | NCI v4.01 |
|
| Hypokalemia | General disorders | MedDRA (Unspecified) |
|
| Hyponatremia | General disorders | NCI v4.01 |
|
| Hypophosphatemia | General disorders | MedDRA (Unspecified) |
|
| INR increased | Blood and lymphatic system disorders | MedDRA (Unspecified) |
|
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) |
|
| Pain | General disorders | MedDRA (Unspecified) |
|
| Paroxysmal atrial tachycardia | Cardiac disorders | MedDRA (Unspecified) |
|
| Sinus tachycardia | Cardiac disorders | MedDRA (Unspecified) |
|
| Urinary retention | Renal and urinary disorders | MedDRA (Unspecified) |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) |
|
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |