TUSC2-nanoparticles and Erlotinib in Stage IV Lung Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
Genprex, Inc.
Study ID
NCT01455389
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DOTAP:Chol-TUSC2 — DRUG
    Starting Dose 0.045 mg/kg by vein on day 1 of each 21 day cycle; Phase II is Maximum Tolerated Dose from Phase I.
  • Erlotinib — DRUG
    Starting Dose 100 mg by mouth each day of a 21 day cycle (except for first week of Cycle 1, if enrolled in Phase II delayed-schedule group). Phase II is Maximum Tolerated Dose from Phase I.
  • Dexamethasone — DRUG
    8 mg orally 24 and 12 hours and 20 mg by vein 30 minutes before DOTAP:Chol-TUSC2 treatment followed by 8 mg orally at 12, 24 and 36 hours after treatment (total number doses = 5).
  • Diphenhydramine — DRUG
    50 mg by mouth or by vein 30 minutes prior to treatment with DOTAP:Chol TUSC2

Study Details

The goal of phase 1 of this clinical research study is to find the highest dose of DOTAP:Chol-TUSC2 that can be safely given in combination with Tarceva (erlotinib hydrochloride) to patients with NSCLC. The goal of phase 2 of this clinical research study is to learn if the combination of DOTAP:Chol-TUSC2 and erlotinib hydrochloride can help to control NSCLC. The safety of this drug combination will also be studied in both phases. DOTAP:Chol-TUSC2 (previously FUS1) is a drug that helps transfer a gene called TUSC2 into cancer cells. Researchers think that cells without this gene may be involved in the development of lung cancer tumors. They want to find out if replacing the gene in these cells may keep the tissue from forming cancer cells. Erlotinib hydrochloride is designed to block a protein on tumor cells that may control tumor growth and survival. This may stop tumors from growing.

Key Dates

First listed
Oct 20, 2011
Start date
Feb 28, 2014
Status verified
Feb 2022
Primary completion
Oct 27, 2016
Completion
Sep 28, 2020

Study Design

Enrollment
25 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DOTAP + Erlotinib
    DOTAP:Chol-TUSC2 0.045 mg/kg by vein over 25-35 minutes on day 1 of each 21 day cycle; and Erlotinib 100 mg by mouth daily for each 21 day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) Level for Drug Treatment Combination [ Time Frame: First 21 day cycle ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
UT MD Anderson Cancer Center· Houston, TX

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