Cytalux for Lung Metastasis in Children

(Cytalux Trial)

Overseen By Timothy Lautz, MD

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must not be taking: Folate supplements

Disqualifiers: Anaphylaxis, Allergy, Renal impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Pediatric subjects aged 6-17 with biopsy confirmed cancer and imaging findings suspicious for pulmonary metastatic disease scheduled to undergo pulmonary metastasectomy via and open or minimally invasive approach.

Will I have to stop taking my current medications?

The trial requires participants to stop taking folate, folic acid, or folate-containing supplements 48 hours before the study drug is given. Other medications are not specifically mentioned, so it's best to discuss with the study team.

What makes the drug Cytalux unique for treating lung metastasis in children?

Cytalux is unique because it is designed to help surgeons see cancerous tissue more clearly during surgery by making the cancer cells glow, which is different from traditional treatments that focus on killing cancer cells directly. ^{1 2 3 4 5}

Research Team

Timothy Lautz, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

This trial is for children aged 6-17 with certain types of cancer like osteosarcoma, who are scheduled for lung surgery to remove suspected metastases. They must weigh at least 20 kg and agree to use contraception or practice abstinence if applicable. Children under 12 need guardian consent, while those 12-17 must also give assent.

Inclusion Criteria

I am not pregnant and agree to use contraception or practice abstinence during the study.

Willingness of research participant or legal guardian/representative to give written informed consent

Female participants must agree to not donate ova from consent until 30 days after study intervention

Exclusion Criteria

I am allergic to ingredients in CYTALUX™.

My liver tests are significantly higher than normal, but I might have Gilbert's syndrome.

Presence of any psychological, familial, sociological condition, or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Preparation

Subjects will be dosed with 0.025 mg/kg CYTALUX (pafolacianine) injection intravenously from 4 hours to up to 24 hours prior to surgery.

1 day

Surgery and Imaging

Subjects undergo pulmonary metastasectomy with near-infrared imaging using CYTALUX to identify and resect metastatic nodules.

1 day

Follow-up

Participants are monitored for treatment-emergent adverse events (TEAEs) and safety of the intervention.

30 days

Treatment Details

Interventions

• Cytalux

Trial Overview The trial is testing the safety and feasibility of using Cytalux during surgery in pediatric patients. Cytalux helps surgeons see cancerous cells better to potentially improve the removal process during pulmonary metastasectomy.

Participant Groups

Group I: Cytalux with Near Infrared Imaging Experimental Treatment 1 Intervention

All participants will receive Cytalux and undergo near infrared imaging.

Cytalux is already approved in United States for the following indications:

Approved in United States as Cytalux for:

• Ovarian cancer
• Lung cancer

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

On Target Laboratories, LLC

Industry Sponsor

Trials

8

Recruited

470+

Findings from Research

In a study of 30 patients with brain metastases from non-small cell lung cancer (NSCLC), combination chemotherapy with cisplatin, ifosfamide, and irinotecan resulted in a 50% response rate in brain lesions, indicating significant efficacy.

The median survival time for these patients was 382 days, with a 1-year survival rate of 56.1%, suggesting that this chemotherapy regimen may improve outcomes for patients with brain metastases from NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination chemotherapy of cisplatin, ifosfamide, and irinotecan with rhG-CSF support in patients with brain metastases from non-small cell lung cancer. Fujita, A., Fukuoka, S., Takabatake, H., et al.[2018]

Topotecan showed some efficacy in treating brain metastases from small cell lung cancer (SCLC), with objective responses in 2 out of 3 patients, but had limited effectiveness in other types of brain metastases, leading to early termination of the study with 19 patients.

The treatment was associated with significant hematological toxicity, including severe neutropenia (37%), thrombocytopenia (21%), and anemia (16%), which raises concerns about its safety, particularly in elderly patients or those with poor health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topotecan in the treatment of brain metastases. A phase II study of GOIM (Gruppo Oncologico dell'Italia Meridionale). Lorusso, V., Galetta, D., Giotta, F., et al.[2013]

In a trial involving 43 chemonaive non-small-cell lung cancer patients with brain metastases, the combination of pemetrexed and cisplatin showed a significant objective response rate of 41.9% for brain metastases, indicating its efficacy as a first-line treatment.

The treatment was generally well-tolerated, with manageable side effects, including some grade 3-4 hematological toxicities, and resulted in a median survival time of 7.4 months, which is promising for a population with typically poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pemetrexed and cisplatin as first-line chemotherapy for advanced non-small-cell lung cancer (NSCLC) with asymptomatic inoperable brain metastases: a multicenter phase II trial (GFPC 07-01). Barlesi, F., Gervais, R., Lena, H., et al.[2022]

In a study of 159 patients with advanced non-small cell lung cancer, those treated with bevacizumab plus chemotherapy (BV+CT) had a significantly lower incidence of brain metastases (14%) compared to those receiving chemotherapy alone (31%).

Patients receiving BV+CT had better survival rates (33.89%) compared to those on chemotherapy alone (18.64%), particularly benefiting VEGF-positive patients, while high expression of carbonic anhydrase-9 (CA9) was associated with reduced effectiveness of BV treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bevacizumab plus chemotherapy versus chemotherapy alone for preventing brain metastasis derived from advanced lung cancer. Fu, Y., Hu, J., Du, N., et al.[2022]

A patient with brain metastases from small cell lung cancer initially responded well to cranial irradiation, indicating that this treatment can be effective for such cases.

Subsequent recurrences were successfully managed with high-dose intravenous etoposide and teniposide, suggesting that epipodophyllotoxins may be a promising treatment option for CNS metastases of small cell lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Podophyllotoxins for brain metastases of small cell lung cancer. Haaxma-Reiche, H., Berendsen, HH., Postmus, PE.[2019]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Combination chemotherapy of cisplatin, ifosfamide, and irinotecan with rhG-CSF support in patients with brain metastases from non-small cell lung cancer. [2018]

2. Greece pubmed.ncbi.nlm.nih.gov

Topotecan in the treatment of brain metastases. A phase II study of GOIM (Gruppo Oncologico dell'Italia Meridionale). [2013]

3. England pubmed.ncbi.nlm.nih.gov

Pemetrexed and cisplatin as first-line chemotherapy for advanced non-small-cell lung cancer (NSCLC) with asymptomatic inoperable brain metastases: a multicenter phase II trial (GFPC 07-01). [2022]

4. England pubmed.ncbi.nlm.nih.gov

Bevacizumab plus chemotherapy versus chemotherapy alone for preventing brain metastasis derived from advanced lung cancer. [2022]

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

Podophyllotoxins for brain metastases of small cell lung cancer. [2019]