Cytalux for Lung Metastasis in Children

(Cytalux Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Timothy Lautz, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

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

Approved in 1 Jurisdiction

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.

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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.

I will not turn 12 or 18 years old during the study.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Ann & Robert H. Lurie Children's Hospital Chicago, IL

Who Is Running the Clinical Trial?

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

On Target Laboratories, LLC Industry Sponsor

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] Brain metastases develop frequently in patients with non-small cell lung cancer (NSCLC), and the prognosis for these patients is very poor. We evaluated the role of chemotherapy for patients with brain metastases from NSCLC.

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] Topotecan is able to cross the blood-brain barrier (BBB) and has been demonstrated to be active in brain metastases from small cell lung cancer (SCLC).

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] Brain metastases (BM) occur in up to 40% of non-small-cell lung cancer (NSCLC) patients. This trial assessed the safety and efficacy of pemetrexed-cisplatin in this population.

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

Bevacizumab plus chemotherapy versus chemotherapy alone for preventing brain metastasis derived from advanced lung cancer. [2022] This retrospective analysis evaluated the mechanism of bevacizumab plus chemotherapy (BV+CT) for preventing brain metastasis derived from lung cancer. From the total of 159 patients with advanced non-small cell lung cancer (NSCLC), 110 received BV+CT and 49 received CT. After medication, both groups had 15 patients with brain metastases (14 vs 31%, P

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

Podophyllotoxins for brain metastases of small cell lung cancer. [2019] A patient with brain metastases of small cell lung cancer (SCLC) responded initially to cranial irradiation. Recurrences were subsequently successfully treated with high-dose intravenous etoposide (VP 16-213) and teniposide (VM 26). Epipodophyllotoxins are potentially useful for CNS metastases of SCLC.