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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response

Outcome Description:

Change in tumor size will be measured by CT scan using RECIST criteria.

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Monte Shaheen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNM Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

INST 1201

NCT ID:

NCT01607554

Start Date:

April 2012

Completion Date:

December 2018

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung
  • non small cell
  • NSCLC
  • Irinotecan
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Hematology Oncology AssociatesAlbuquerque, New Mexico  87106