Phase II Trial of Lung Chemoemobolization

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT05672108
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Colon Cancer
  • Endobronchial Metastases
  • Lung Metastases From Any Primary
  • Lung Non-Small Cell Carcinoma
  • Mediastinal Neoplasm
  • Pleural Neoplasm
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Computed Tomography — PROCEDURE
    Undergo CT
  • Ethiodized Oil — DRUG
    Given IA
  • Mitomycin — DRUG
    Given IA
  • Transarterial Chemoembolization — PROCEDURE
    Undergo TACE
  • Tris-acryl Gelatin Microspheres — DEVICE
    Given IA

Study Details

This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors. Mitomycin (chemotherapy), Lipiodol (drug carrier), and Embospheres (small plastic beads that block off the artery) are injected into the tumor-feeding artery. This traps the chemotherapy inside the tumor and also cuts off the tumor\'s blood supply. As a result, the tumor is exposed to a high dose of chemotherapy, and is also deprived of nutrients and oxygen. TACE can be effective at controlling or stopping the growth of lung tumors.

Key Dates

Start date
May 12, 2023
Status verified
Mar 2026
Primary completion
Oct 28, 2027
Completion
Oct 28, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lung chemoembolization
    Patients receive lipiodol intra-arterially (IA), mitomycin IA, and embospheres IA and undergo TACE on study. Patients also undergo angiography and computed tomography (CT) at baseline and follow up.

Primary Outcome Measure

Local progression free survival [ Time Frame: Time from the initial transarterial chemoembolization (TACE) treatment to progression in a completely treated territory (or touching the border of a completely treated area), or death from any cause, assessed at 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Franz E. Boas
[email protected]
626-218-8708
Franz E. Boas (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Stephen B. Solomon, MD
[email protected]
212-639-5012
Stephen B. Solomon, MD (PRINCIPAL_INVESTIGATOR)

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