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OncoMatch/Clinical Trials/NCT03093909

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

Is NCT03093909 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Gemcitabine for malignant neoplasm of bone and articular cartilage.

Phase 1RecruitingM.D. Anderson Cancer CenterNCT03093909Data as of May 2026

Treatment: GemcitabineAny 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. The safety and side effects of this drug will also be studied. This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work. Up to 44 participants will be enrolled in this study. All will take part at MD Anderson.

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Melanoma

Disease stage

Metastatic disease required

Performance status

ECOG OR LANSKY 0–2

ECOG <= 2 for patients >= 16 years old or Lansky play >= 60% for patients <=15 years old

Prior therapy

Cannot have received: radiotherapy

Exception: within 2 weeks

No radiotherapy within 2 weeks

Lab requirements

Blood counts

ANC >= 1,000/mm3, platelet count >= 100,000/mm3 (transfusion independent), hemoglobin >= 8.0g/dl (may receive RBC transfusions)

Kidney function

creatinine <= 2 x ULN

Liver function

bilirubin and AST <= 5x ULN

Adequate organ function as defined by: peripheral absolute neutrophil count (ANC) >= 1,000/mm3, platelet count >= 100,000/mm3 (transfusion independent defined as not receiving platelet transfusions within a 7 day period prior to enrollment), hemoglobin >= 8.0g/dl (may receive RBC transfusions), renal-creatinine <= 2 x ULN; hepatic- bilirubin and AST <= 5x ULN; pulmonary: FVC >=50% predicted, Oxyhemoglobin saturation at rest >=95% (off supplemental oxygen).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • The University of Texas MD Anderson Cancer Center · Houston, Texas

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