Photodynamic Therapy for Esophageal Cancer

Not currently recruiting at 3 trial locations

Overseen By David Kelsen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Chemotherapy, Biologic therapy, Immunotherapy

Disqualifiers: Pregnancy, T4 tumors, Esophageal perforation, Heart failure, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safest dose of laser light for WST-11 VTP, a type of photodynamic therapy that helps manage blockages from esophageal cancer. The treatment uses a special drug and laser light together to target cancer in the esophagus. Suitable participants have esophageal cancer that cannot be cured with surgery or radiation and experience swallowing difficulties. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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 prior data suggests that WST 11-mediated VTP therapy is safe for treating esophageal cancer?

Research shows that WST-11 VTP therapy is generally safe for people. In earlier studies, WST-11 left the body quickly, with half of it gone in about 40 minutes. This rapid clearance helps keep side effects low.

Importantly, WST-11 does not accumulate in the body, enhancing its safety and reducing the chance of unwanted effects. Patients in past studies experienced only minor side effects, such as fluid buildup around the lungs, known as pleural effusions.

Overall, these early findings suggest that WST-11 VTP therapy is safe for people, though the current trial aims to confirm the safest dose. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for esophageal cancer, which typically involve surgery, chemotherapy, or radiation, WST 11-mediated VTP therapy offers a unique approach by using light-activated therapy to target the tumor's blood vessels directly. This treatment involves administering WST11 intravenously, which is then activated by laser light during an endoscopy procedure, leading to precise tumor destruction with potentially fewer side effects. Researchers are excited because this method could provide a less invasive and more targeted option for patients, reducing damage to surrounding healthy tissues and possibly leading to quicker recovery times.

What evidence suggests that WST 11-mediated VTP therapy might be an effective treatment for esophageal cancer?

Research shows that WST 11-mediated vascular-targeted photodynamic therapy (VTP), which participants in this trial will receive, may be effective for esophageal cancer. An earlier study found that 94% of patients responded to the treatment within the first 30 days. Half of these patients experienced a complete response, with no detectable cancer, while 44% had a partial response, showing some reduction in cancer. After some patients received a second round of treatment, the complete response rate increased to 68%. This therapy uses a special drug and light to target and destroy cancer cells, helping to clear blockages in the esophagus. Although early results are promising, more research is needed to confirm its long-term effectiveness. ^{1 2 3 5 6}

Who Is on the Research Team?

Hans Gerdes, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10265489/

Final Results of a Phase I Trial of WST-11 (TOOKAD ... The initial 30-day treatment response rate was 94% (50% complete, 44% partial). Eight patients underwent a second treatment, with a final observed 68% complete ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03133650

A Trial of a New Type of Photodynamic Therapy (VTP) in ... 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.

3. meetings.asco.org meetings.asco.org/abstracts-presentations/120243

Abstract Here we evaluate WST11-VTP for the treatment of obstructive esophageal cancer aiming at developing clinically relevant protocol. Methods: Using endoscopy guided ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8430498/

Photodynamic Therapy: A Compendium of Latest Reviews In Reference [32], it was concluded that palliative PDT in bile duct cancer improves survival but increases the risk of cholangitis and liver ...

5. researchgate.net researchgate.net/publication/317945021_P-003A_novel_vascular_targeted_photodynamic_therapy_VTP_in_orthotopic_rat_model_for_the_treatment_of_esophageal_cancer

P-003A novel vascular targeted photodynamic therapy (VTP) in ... Photodynamic therapy is an effective palliative treatment of esophageal cancer. Minor complications associated with this therapy include pleural effusions ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1572100024004241

Clinical and pre-clinical advances in the PDT/PTT strategy ... This review summarizes recently published clinical trials that used PDT/PTT to diagnostic or treat cancers of breast, prostate, skin, and other tissues.