TACE for Lung Cancer

Recruiting at 1 trial location

Overseen By Franz Edward Boas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: 1 day (procedure)

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called transarterial chemoembolization (TACE) to evaluate its effectiveness for patients with non-small cell lung cancer or lung metastases. TACE delivers chemotherapy directly to the tumor's blood supply and blocks it, concentrating the drugs on the cancer while depriving it of nutrients and oxygen. This trial may suit those whose lung cancer worsens despite other treatments and who have most of their tumor volume in the chest. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

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 prior data suggests that transarterial chemoembolization is safe for treating lung cancer?

Research has shown that treatments combining mitomycin with transarterial chemoembolization (TACE) are generally well-tolerated. One study reported no serious side effects when using this method for lung tumors. The procedure involves injecting chemotherapy directly into the arteries that feed the tumor and then blocking the blood flow, which helps retain the drug in the tumor. This approach achieved a 40% success rate in slowing or stopping tumor growth in some patients.

Another study found that this treatment was technically successful 100% of the time, with no major side effects immediately after the procedure. Overall, these findings suggest that this combination is safe for patients, with few significant side effects during the trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using transarterial chemoembolization (TACE) with mitomycin for lung cancer because it offers a targeted approach that combines direct drug delivery and embolization. Unlike standard chemotherapy that circulates throughout the body, TACE delivers mitomycin directly to the tumor via the arteries, maximizing the treatment's impact while minimizing systemic side effects. Additionally, the embolization component helps block the blood supply to the tumor, potentially enhancing the effectiveness of the chemotherapy. This dual-action method could lead to better outcomes and fewer side effects compared to traditional lung cancer treatments.

What evidence suggests that transarterial chemoembolization is effective for lung cancer?

Research has shown that transarterial chemoembolization (TACE), which participants in this trial will receive, can slow tumor growth in people with non-small cell lung cancer (NSCLC). One study found that one month after TACE treatment, 42% of patients experienced tumor shrinkage. After six months, this number was 26%. Additionally, one month after treatment, 90% of patients had their disease under control, meaning their tumors either shrank or remained the same size. The chemotherapy drug used in TACE, mitomycin, has also proven effective on its own, with about 25% of NSCLC patients responding to it. By combining TACE's targeted method with mitomycin's effectiveness, this treatment may offer a promising way to manage lung tumors. ^{6 7 8 9 10}

Who Is on the Research Team?

Franz E. Boas

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Mitomycin
• Transarterial Chemoembolization

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.

How Is the Trial Designed?

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 United States, European Union, Japan for the following indications:

Approved in United States as Mitomycin-C for:

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

Approved in European Union as Mitomycin-C for:

• Gastric adenocarcinoma
• Pancreatic adenocarcinoma
• Breast cancer
• Non-small cell lung cancer
• Cervical cancer

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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 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]

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 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]

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 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]

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]

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 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]

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]

Citations

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Mitomycin C enhanced the efficacy of PD-L1 blockade ... Mitomycin C enhanced the efficacy of PD-L1 blockade in non-small cell lung cancer · Discussion · Conclusion · Supplementary information.

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Mitomycin C treatment induces resistance and enhanced ... Indeed, our results indicate that using p-Akt inhibitors could improve the efficacy of MMC in lung cancer cells with high endogenous p-Akt expression. ...

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Efficacy and safety of combination chemotherapy with ... Mitomycin is a second generation drug which has proven activity as a single agent in the treatment of NSCLC with a response rate of approximately 25% [7].

4. ascopubs.org ascopubs.org/doi/10.1200/jco.2005.23.16_suppl.7337

Docetaxel (T) and mitomycin C (M) as second-line ... On an intent-to-treat analysis, 1 pt achieved CR, 3 PR, 17 SD, 25 PD and 3 NE due to protocol deviation (n=1) and no measurable disease (n=2), resulting in an ...

5. clinicaloncologyonline.net clinicaloncologyonline.net/article/S0936-6555(01)99320-3/abstract

Mitomycin C, Vinblastine and Carboplatin All treatment was administered on an outpatient basis. The overall objective response rate was 30%; the symptomatic response rate was 60%, which was exactly ...

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Phase II trial of lung chemoembolization - PMC There were no serious adverse events, and the metabolic response rate was 40%. All lung metastases were hypervascular, and lipiodol was ...

7. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/380035

Phase II Trial of Lung Chemoemobolization This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1051044323005936

Phase II Trial of Lung Chemoembolization There were no serious adverse events, and the metabolic response rate was 40%. All lung metastases were hypervascular, and ethiodized oil was preferentially ...

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Bronchial or Pulmonary Artery Chemoembolization for ... Key Results: Technical efficacy was 100% with no immediate major adverse events reported. Forty percent of patients showed partial metabolic ...

10. jgo.amegroups.org jgo.amegroups.org/article/view/26419/html

Long-term follow-up after conventional transarterial ... Conclusions: c-TACE with mitomycin was effective and safe in this long-term follow-up study. Risk of death was significantly higher in patients without ...