Aerosol Gemcitabine for Solid Tumors with Lung Metastases
This study is testing gemcitabine, an FDA-approved cancer drug, when given as a mist that you breathe in (aerosol gemcitabine). The goal is to find the highest safe dose of aerosol gemcitabine for people aged 12 to 50 who have solid tumors that have spread to their lungs. These are tumors for which there isn't a known cure or therapy that significantly improves life quality. The study will also look at any side effects. Up to 44 participants will join this study, which is currently unclear if it's recruiting.
- Study design
- This is an interventional study with an unclear phase, planning to enroll up to 44 participants. Participants will be assigned to different dose levels of gemcitabine.
- What's involved
- You would take gemcitabine as a mist twice a week for 4 weeks per cycle, for up to 12 cycles. This treatment will be given at MD Anderson, and you will need to comply with safety monitoring.
- Compensation
- Not stated in the trial record.
- Follow-up
- Toxicities of aerosol gemcitabine will be reviewed with each 4-week cycle, up to 24 weeks for six dose levels.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases
At a glance
Conditions
NCT03093909
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
The University of Texas MD Anderson Cancer Center
Houston, Texasno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Najat C. Daw-Bitar, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB)4 weeks
MTD is defined as highest dose level with six patients with at most 1 dose limiting toxicity (DLT) occurring during cycle 1. Dose levels will continue to be increased until 1 participant experiences DLT. If only 1 of 3 participants experiences DLT, 3 additional patients will be entered. Dose escalation conducted via accelerated titration method for first 2 dose levels followed by 3+3 method for remaining dose levels. Cohorts of 1 participant per dose level for first 2 dose levels. If at any time during cycle 1 there is an instance of pulmonary grade 2 toxicity or pulmonary function tests (PFT) decline\>10% related to study drug, current dose level expanded to 3 participants \& switched to 3+3 design. If neither of these nor any other DLT occur in dose levels 1-2, switch will be to the 3 + 3 design beginning with dose level 3. Three participants will be treated at dose level 3, if still no DLT, 3 more treated at dose level 4.
- Toxicities of Aerosol Gemcitabine (GCB)Reviewed with each 4 week cycle, up to 24 weeks for six dose levels
Dose limiting toxicities associated with the MTD of aerosol GCB using the NCI Common Terminology Criteria version 4 for Adverse Events (CTCAE) will be utilized for AE reporting. DLT defined as any of the following events that are at least (possibly, probably or definitely) attributable to aerosol GCB. The observation period for the purposes of dose-escalation will be the first cycle of therapy. DLT Definition includes: * Any episode of respiratory (bronchospasm, cough and/or dyspnea) grade 2 toxicity. * or \> 10% decrease in FEV1 that persists \> 3 days after the drug is stopped or recurrent episode of respiratory (bronchospasm, cough and/or dyspnea) grade 2 toxicity. * Any grade 3 or 4 non-hematological toxicity. * Any grade 4 neutropenia or thrombocytopenia.