Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Gemcitabine for Malignant Neoplasm of Bone and Articular Cartilage

Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.

Official registry: https://clinicaltrials.gov/study/NCT03093909 · M.D. Anderson Cancer Center · enrollment listed as 44

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Gemcitabine. The registry lists allocation as na. Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant.

They plan to enroll about 44 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases

Interventions: Gemcitabine

Primary outcome (registry wording): Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB)

Who it is for (from inclusion criteria)

  • Ages 12 Years to 50 Years
  • Patients with diagnosis of solid tumor with lung metastases and patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life
  • Patient age \>/= 12 years and \</= 50 years
  • Performance Status: ECOG \</= 2 for patients \>/= 16 years old or Lansky play \>/= 60% for patients \</=15 years old
  • Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to NCI CTCAE Grade \</= 1 or to the baseline laboratory values as defined in the who can join
  • No radiotherapy within 2 weeks
  • Subjects who received GCB systemically previously are eligible for participation

Public study contact (from the registry)

Najat C. Daw-Bitar, MD

713-792-3280

ndaw@mdanderson.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT03093909 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT03093909?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT03093909?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary