TACE for Lung Cancer

Recruiting at1 trial location

Overseen by Franz E. Boas

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: City of Hope Medical Center

Disqualifiers: Pulmonary hypertension, Heart failure, Renal failure, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a treatment called TACE for patients with non-small cell lung cancer that doesn't respond to other treatments. TACE involves injecting chemotherapy directly into the tumor's blood supply and blocking it, trapping the drugs inside and cutting off nutrients and oxygen to the tumor.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment TACE for lung cancer?

Research shows that transcatheter arterial chemoembolization (TACE) can improve the quality of life and clinical outcomes for lung cancer patients, while also reducing side effects. Additionally, TACE with mitomycin has been effective in treating other cancers, like liver cancer, by increasing survival rates and reducing tumor size. ^{1 2 3 4 5}

Is TACE with Mitomycin-C safe for humans?

Mitomycin-C, used in TACE, can cause side effects like low blood cell counts, anemia, and nausea. Rare but serious side effects include lung inflammation and heart problems. ^{6 7 8 9 10}

How is the TACE treatment for lung cancer different from other treatments?

TACE (Transarterial Chemoembolization) for lung cancer is unique because it delivers chemotherapy drugs like Mitomycin directly to the tumor through the blood vessels, which can improve effectiveness and reduce side effects compared to traditional chemotherapy that circulates throughout the body. ^{1 2 3 11 12}

Research Team

Franz E. Boas

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

Adults with non-small cell lung cancer that's gotten worse on standard treatments or who can't handle those treatments. They should have a majority of their tumor in the chest and not be candidates for surgery, thermal ablation, or ablative radiation. Excluded are pregnant individuals, those with certain heart and lung conditions, severe kidney failure, mental status changes affecting consent/follow-up, specific blood disorders, hyperthyroidism history including subclinical cases, allergies to trial drugs or iodinated contrast that can't be managed premedication.

Inclusion Criteria

Most of my cancer is located in my chest.

My lung cancer is getting worse despite treatment, and surgery or targeted therapies are not options for me.

I am 18 years old or older.

Exclusion Criteria

My kidney function is severely reduced.

Platelets < 50,000 (after transfusion, if needed)

I have had a lung clot in the last 3 months.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive lung chemoembolization using Lipiodol, mitomycin, and Embospheres. Response to treatment is evaluated on CT scans.

1 day (procedure)

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CT scans and evaluation of lipiodol retention.

4-6 weeks

2 visits (in-person)

Long-term follow-up

Progression-free survival and overall survival are monitored.

Up to 9 months

Treatment Details

Interventions

• Mitomycin (Anti-tumor antibiotic)
• Transarterial Chemoembolization (Procedure)

Trial Overview The trial is testing transarterial chemoembolization (TACE) for treating non-small cell lung cancer. TACE involves injecting chemotherapy directly into the artery feeding the tumor along with substances to block this artery—trapping chemotherapy within the tumor and cutting off its nutrient supply.

Participant Groups

Group I: Lung chemoembolization Experimental Treatment 5 Interventions

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.

Mitomycin is already approved in Japan for the following indications:

Approved in Japan as Mitomycin-C for:

• Gastric cancer
• Pancreatic cancer
• Breast cancer
• Lung cancer
• Cervical cancer
• Head and neck cancer

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Findings from Research

Transcatheter arterial chemoembolization (TACE) demonstrated significantly better clinical efficacy compared to traditional bronchial artery infusion (BAI) in treating lung cancer, based on a study of 513 inpatients.

Patients receiving TACE experienced improved pulmonary function, lower incidence of adverse reactions, and greater enhancements in quality of life and emotional well-being compared to those receiving BAI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter arterial chemoembolization improves clinical efficacy and life quality of patients with lung cancer and reduces adverse reactions. Jin, SQ., Zhao, HY., Bai, B., et al.[2021]

In a study of 51 patients with unresectable hepatocellular carcinoma, TACE using multiple anticancer drugs did not show a significant improvement in radiographic response or progression-free survival compared to TACE using epirubicin alone.

However, the multi-drug TACE group experienced significantly more severe liver enzyme elevation and hepatic artery abnormalities, indicating potential safety concerns with this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective evaluation of transcatheter arterial chemoembolization (TACE) with multiple anti-cancer drugs (epirubicin, cisplatin, mitomycin c, 5-fluorouracil) compared with TACE with epirubicin for treatment of hepatocellular carcinoma. Sahara, S., Kawai, N., Sato, M., et al.[2022]

In a study of 60 patients with unresectable hepatocellular carcinoma treated with conventional transarterial chemoembolization (c-TACE) using mitomycin, the overall survival rates were 72.1% at 1 year, 47.8% at 3 years, and 39.3% at 5 years, indicating the treatment's effectiveness over the long term.

Patients who achieved an objective tumor response (complete or partial response) had a significantly lower risk of death compared to those with progressive disease, highlighting the importance of treatment response in predicting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after conventional transarterial chemoembolization (c-TACE) with mitomycin for hepatocellular carcinoma (HCC). Yamada, R., Bassaco, B., Bracewell, S., et al.[2022]

In a study involving 162 patients with hepatocellular carcinoma, transarterial chemoembolization (TACE) using a triple-drug regimen (doxorubicin, mitomycin C, and gemcitabine) resulted in the longest overall survival (20.5 months) and time to progression (6.8 months) compared to single-drug and double-drug regimens.

The objective response rate (ORR) was significantly higher in the triple-drug group (56.6%) compared to the single-drug (22.0%) and double-drug (40.7%) groups, indicating that using multiple chemotherapeutic agents can enhance tumor response and improve patient prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Agent versus Combination Doxorubicin-Based Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma: A Single-Blind, Randomized, Phase II Trial. Liu, B., Huang, JW., Li, Y., et al.[2022]

In a study involving 20 patients with various types of intractable cancer, selective intraarterial infusion of mitomycin C microcapsules (MMC-mc) led to significant tumor size reductions in 14 patients, demonstrating its efficacy as a treatment option.

The treatment was well-tolerated with mild systemic toxicity, and it not only reduced tumor size but also improved symptoms like pain and dysuria, indicating its potential as both a preoperative and palliative measure for invasive carcinomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial chemoembolization with mitomycin C microcapsules in the treatment of primary or secondary carcinoma of the kidney, liver, bone and intrapelvic organs. Kato, T., Nemoto, R., Mori, H., et al.[2019]

Mitomycin C (MMC) is a well-studied antitumor antibiotic that works best in low-oxygen (anaerobic) environments and has shown effectiveness against various cancers, including gastric, pancreatic, and breast cancer.

Despite its broad efficacy, MMC is associated with significant side effects like thrombocytopenia and leucocytopenia, as well as rare but serious conditions such as hemolytic uremic syndrome and cardiac failure, which limit its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitomycin C: mechanism of action, usefulness and limitations. Verweij, J., Pinedo, HM.[2022]

In a phase II study involving 14 patients with non-small cell lung cancer, bronchial artery infusion of mitomycin C (MMC) resulted in a partial response in only 1 patient, leading to a response rate of 7.1%.

The treatment was associated with several toxic effects, including anemia (35.7%) and leukopenia (28.6%), indicating that while there may be some efficacy, the safety profile raises concerns about its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Phase II study of bronchial artery infusion of mitomycin C in non-small cell lung cancer]. Nakamura, Y., Shimizu, E., Hohjo, F., et al.[2013]

In a study of 12 colorectal cancer patients with liver metastases, the pharmacokinetics of mitomycin C (MMC) were found to be similar to those reported for intravenous or intraarterial injections, indicating consistent drug behavior during treatment.

The study showed that the embolization procedure did not reduce systemic exposure to MMC, suggesting that the method used for delivering the drug is effective without compromising its availability in the bloodstream.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of intraarterial mitomycin C in the chemoembolisation treatment of liver metastases. Rump, AF., Botvinik-Helling, S., Theisohn, M., et al.[2019]

Mitomycin C intravascular chemoembolization (MICE) showed no intraoperative or postoperative complications in a small case series of three patients, indicating a safe application for treating corneal neovascularization.

All three patients experienced significant improvements in visual acuity, with two achieving 20/20 vision and no recurrence of corneal neovascularization or lipid keratopathy at follow-up periods ranging from 4 months to 1 year, suggesting MICE's efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial outcomes of mitomycin intravascular chemoembolization (MICE) for corneal neovascularization. Mimouni, M., Ouano, D.[2022]

In a study of 100 eyes treated with mitomycin C (MMC) for ocular surface neoplasia, 34% of cases experienced allergic reactions, and 14% developed epiphora due to punctal stenosis, indicating these are common complications.

Despite these issues, no serious complications were reported, suggesting that MMC is a safe treatment option for ocular surface neoplasia over a mid-term follow-up period of approximately 26.5 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of mitomycin C therapy in 100 eyes with ocular surface neoplasia. Khong, JJ., Muecke, J.[2022]

In a study of 119 patients with lung metastases treated with transarterial chemoembolization (TACE), the inferior phrenic artery (IPA) was identified as a significant blood supply source for some metastatic lesions, particularly those in the lower lung lobe.

The TACE procedure was safe, with no serious complications reported, and resulted in an average survival time of 14.7 months for patients after diagnosis, highlighting the efficacy of targeting the IPA for complete embolization of lung metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of inferior phrenic artery in the interventional treatment of lung metastases tumor: A report of 11 cases. Zhu, LZ., Yang, RJ., Zhu, X.[2022]

Mitomycin C (MMC) remains a widely used antineoplastic agent, but its administration is limited to middle-dose intermittent methods to minimize side effects, highlighting the need for careful management in treatment.

Recent reports indicate potential adverse effects, such as hemolytic-uremic syndrome, necessitating further research into the mechanisms of MMC's therapeutic actions and its side effects to improve its application and explore new derivatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Advances in mitomycin studies--clinical studies: progress over 10 years]. Taguchi, T.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcatheter arterial chemoembolization improves clinical efficacy and life quality of patients with lung cancer and reduces adverse reactions. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Prospective evaluation of transcatheter arterial chemoembolization (TACE) with multiple anti-cancer drugs (epirubicin, cisplatin, mitomycin c, 5-fluorouracil) compared with TACE with epirubicin for treatment of hepatocellular carcinoma. [2022]

3. China pubmed.ncbi.nlm.nih.gov

Long-term follow-up after conventional transarterial chemoembolization (c-TACE) with mitomycin for hepatocellular carcinoma (HCC). [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Single-Agent versus Combination Doxorubicin-Based Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma: A Single-Blind, Randomized, Phase II Trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Arterial chemoembolization with mitomycin C microcapsules in the treatment of primary or secondary carcinoma of the kidney, liver, bone and intrapelvic organs. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Mitomycin C: mechanism of action, usefulness and limitations. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

[Phase II study of bronchial artery infusion of mitomycin C in non-small cell lung cancer]. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of intraarterial mitomycin C in the chemoembolisation treatment of liver metastases. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Initial outcomes of mitomycin intravascular chemoembolization (MICE) for corneal neovascularization. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Complications of mitomycin C therapy in 100 eyes with ocular surface neoplasia. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Role of inferior phrenic artery in the interventional treatment of lung metastases tumor: A report of 11 cases. [2022]

12. Japan pubmed.ncbi.nlm.nih.gov

[Advances in mitomycin studies--clinical studies: progress over 10 years]. [2013]