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

Conditions

• Malignant Neoplasm of Bone and Articular Cartilage
• Malignant Neoplasm of Male Genital Organs
• Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma
• Malignant Neoplasms of Female Genital Organs
• Malignant Neoplasms of Independent (Primary) Multiple Sites
• Malignant Neoplasms of Lip Oral Cavity and Pharynx
• Malignant Neoplasms of Mesothelial and Soft Tissue
• Malignant Neoplasms of Thyroid and Other Endocrine Glands
• Malignant Neoplasms of Urinary Tract
• Melanoma and Other Malignant Neoplasms of Skin

Eligibility Criteria

Sex

ALL

Age

12 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Gemcitabine — DRUG
  Nebulized dose of aerosol GCB twice a week continuously (escalating treatment dose schema, starting at 0.75 mg/kg to 3.0 mg/kg). Participants receive a pre-determined volume of nebulized solution, according to the dose level and weight of the participant, with each aerosol GCB administration. One cycle is 4 weeks in duration.

Study Details

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. 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.

Key Dates

Start date

Nov 22, 2017

Status verified

May 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

44 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Aerosol Gemcitabine (GCB)
  Dose Escalation Cohort: Participants take Gemcitabine by mist 2 times each week for 4 weeks (28 days). Expansion Cohort: Participants with OS lung metastases receive study drug at the maximum tolerated dose from Dose Escalation Cohort. Participants may continue to receive the study drug for up to 12 cycles per decision of doctor.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB) [ Time Frame: 4 weeks ]

Central Contacts

• Najat C. Daw-Bitar, MD
  713-792-3280
  [email protected]

Locations (1)

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