RECRUITING

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

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Conditions

Malignant Neoplasm of Bone and Articular CartilageMalignant Neoplasms of Female Genital OrgansMalignant Neoplasms of Independent (Primary) Multiple SitesMalignant Neoplasms of Lip Oral Cavity and PharynxMalignant Neoplasm of Male Genital OrgansMalignant Neoplasms of Mesothelial and Soft TissueMalignant Neoplasm of Respiratory and Intrathoracic Organ CarcinomaMalignant Neoplasms of Thyroid and Other Endocrine GlandsMalignant Neoplasms of Urinary TractMelanoma and Other Malignant Neoplasms of SkinSolid Tumors and Pulmonary Metastasesaerosol gemcitabineaerosol GCBLung metastasesosteosarcoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-11-22
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03093909

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 2. Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs).
  3. 3. 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).
  4. 4. Patient age \>/= 12 years and \</= 50 years.
  5. 5. Performance Status: ECOG \</= 2 for patients \>/= 16 years old or Lansky play \>/= 60% for patients \</=15 years old.
  6. 6. 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 inclusion criteria.
  7. 7. No radiotherapy within 2 weeks.
  8. 8. Subjects who received GCB systemically previously are eligible for participation.
  1. 1. Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from asthma as a child and outgrew it.
  2. 2. Pregnant or breastfeeding women will not be entered into this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in females who are post-menarchal and of child bearing potential (e.g. female that has not been amenorrheic for at least 12 consecutive months or surgically sterilized). Males or females of reproductive potential will not participate unless they have agreed to use effective contraception for the entire period in which they are receiving protocol therapy and for at least one month after treatment ends. Effective contraception is defined as intrauterine device (IUD), hormonal (birth control pill, injections, implants, patch), tubal ligation and partner's vasectomy. Abstinence is an acceptable method of birth control.
  3. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  4. 4. Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \>/= 2 (CTCAE v4.0).
  5. 5. Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy.
  6. 6. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Grade \</= 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (eg, hearing loss).

Contacts and Locations

Study Contact

Najat C. Daw-Bitar, MD
CONTACT
713-792-3280
ndaw@mdanderson.org

Principal Investigator

Najat C. Daw-Bitar, MD
PRINCIPAL_INVESTIGATOR
The University of Texas MD Anderson Cancer Center

Study Locations (Sites)

The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Najat C. Daw-Bitar, MD, PRINCIPAL_INVESTIGATOR, The University of Texas MD Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-11-22
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2017-11-22
Study Completion Date2025-11-30

Terms related to this study

Keywords Provided by Researchers

  • Solid Tumors and Pulmonary Metastases
  • aerosol gemcitabine
  • aerosol GCB
  • Lung metastases
  • osteosarcoma

Additional Relevant MeSH Terms

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