Photodynamic Therapy for Esophageal Cancer

Recruiting at 2 trial locations

Overseen By David Kelsen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

12 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to treat obstruction from esophageal cancer that can be safely given.

Will I have to stop taking my current medications?

The trial requires that you have not received any systemic therapy (like chemotherapy or immunotherapy) within 7 days before treatment. If you are on anticoagulation medication, it may need to be temporarily stopped if your doctor thinks it's safe.

What data supports the effectiveness of the treatment WST 11-mediated VTP therapy for esophageal cancer?

Research shows that WST11, used in a similar treatment for melanoma tumors, achieved significant tumor reduction and cure rates, suggesting its potential effectiveness in other cancers like esophageal cancer. ^{1 2 3 4 5}

Is photodynamic therapy safe for esophageal cancer patients?

Photodynamic therapy (PDT) using talaporfin sodium has been shown to be generally safe for esophageal cancer patients, with no severe skin reactions and manageable side effects like esophageal stricture, which can be treated with endoscopic procedures. ^{1 6 7 8 9}

How is WST 11-mediated VTP therapy different from other treatments for esophageal cancer?

WST 11-mediated VTP therapy is unique because it targets the blood vessels supplying the tumor rather than the cancer cells directly, using a light-activated process to cut off the tumor's blood supply and induce cell death. This approach can also stimulate the immune system to help fight the cancer, which is different from traditional treatments that primarily target the cancer cells themselves. ^{2 4 10 11 12}

Research Team

Hans Gerdes, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with esophageal cancer that's inoperable or has spread to other organs. They should have a performance status indicating they can still carry out daily activities and must not have had recent systemic therapy. Adequate organ function is required, and women of childbearing potential must test negative for pregnancy and use contraception.

Inclusion Criteria

I've had esophageal dilation but my swallowing difficulties returned.

I haven't had any cancer treatments like chemotherapy or immunotherapy in the last week.

I am able to live at home and care for most of my personal needs.

Exclusion Criteria

Pregnant or breast-feeding women. Women of childbearing potential (WOCBP) must undergo a negative pregnancy test (either serum or urine) prior to study entry. Both sexes must use contraception while on study. WOCBP include: Any woman who has experienced menarche and who has not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy) or who is not post-menopausal (defined as amenorrheic ≥12 consecutive months); Women on hormone replacement therapy with documented serum follicle stimulating hormone level > 35 mIU/ml; Women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as intrauterine device or barrier methods to prevent pregnancy or are practicing abstinence of where the partner is sterile; T4 tumors with involvement of any adjacent structure, including the trachea, aorta or pleura; Prior history of esophageal perforation; Any other medical or psychiatric comorbidities, including decompensated heart failure, unstable angina or coronary artery disease or severe pulmonary disease, that, in the opinion of the study investigator, would make the patient a poor candidate for the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vascular-targeted photodynamic therapy (VTP) using WST11, administered intravenously at a dose of 4 mg/kg, followed by immediate laser light application during an endoscopy procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Treatment Details

Interventions

• WST 11-mediated VTP therapy

Trial Overview The study tests the highest safe dose of WST-11 VTP, a new photodynamic therapy using laser light to treat swallowing difficulties caused by esophageal cancer obstruction.

Participant Groups

Group I: Vascular-targeted photodynamic therapy (VTP) using WST11 Experimental Treatment 1 Intervention

Participants will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes, during an endoscopy procedure, followed by immediate laser light application.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Steba Biotech S.A.

Collaborator

Trials

17

Recruited

1,300+

Weizmann Institute of Science

Collaborator

Trials

60

Recruited

39,700+

Findings from Research

WST11, a novel compound for vascular-targeted photodynamic therapy, shows rapid clearance from circulation in mice (1.65 min) and rats (7.5 min), indicating a quick systemic elimination which is important for minimizing side effects.

In treating M2R melanoma xenografts, WST11-VTP resulted in 100% tumor flattening and a 70% cure rate at a dose of 9 mg/kg, demonstrating its efficacy as a therapeutic agent in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

WST11, a novel water-soluble bacteriochlorophyll derivative; cellular uptake, pharmacokinetics, biodistribution and vascular-targeted photodynamic activity using melanoma tumors as a model. Mazor, O., Brandis, A., Plaks, V., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

The role of photodynamic therapy (PDT) in inoperable oesophageal cancer. [2019]

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

WST11, a novel water-soluble bacteriochlorophyll derivative; cellular uptake, pharmacokinetics, biodistribution and vascular-targeted photodynamic activity using melanoma tumors as a model. [2019]

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

Clinical Efficacy of HiPorfin Photodynamic Therapy for Advanced Obstructive Esophageal Cancer. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Medium-term Follow-up of Vascular-targeted Photodynamic Therapy of Localized Prostate Cancer Using TOOKAD Soluble WST-11 (Phase II Trials). [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Palliation of advanced esophageal carcinoma by photodynamic therapy and irradiation. [2019]

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

A multicenter phase II study of salvage photodynamic therapy using talaporfin sodium (ME2906) and a diode laser (PNL6405EPG) for local failure after chemoradiotherapy or radiotherapy for esophageal cancer. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Photodynamic Therapy Using Talaporfin Sodium for Local Failure after Chemoradiotherapy or Radiotherapy for Esophageal Cancer: A Single Center Experience. [2020]

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

Esophageal dysmotility in patients undergoing photodynamic therapy. [2013]

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

Evaluation on Short-Term Therapeutic Effect of 2 Porphyrin Photosensitizer-Mediated Photodynamic Therapy for Esophageal Cancer. [2020]

10. China pubmed.ncbi.nlm.nih.gov

[Mechanism of photodynamic therapy against human esophageal carcinoma xenografts in nude mice]. [2009]

11. Germany pubmed.ncbi.nlm.nih.gov

Systemic antitumor protection by vascular-targeted photodynamic therapy involves cellular and humoral immunity. [2021]

12. Greece pubmed.ncbi.nlm.nih.gov

Novel zinc phthalocyanine as a promising photosensitizer for photodynamic treatment of esophageal cancer. [2021]