20 Participants Needed

X-PACT for Advanced Cancers

Recruiting at 3 trial locations
SN
LW
Overseen ByLauren Wood, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

In this Phase I trial for subjects with advanced head \& neck cancer, breast cancer, soft tissue sarcoma or melanoma all subjects will receive open label X-PACT treatment as a intra-tumoral injection. The primary objective will be to establish the safety of X-PACT when dosed with 5 intra-tumoral injections of the combination product (the phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) over a period of 6 weeks (on day D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6). After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart. Treatment will be considered safe provided ≤ 2 out of 12 patients experience a dose-limiting toxicity (DLT) during the 6 weeks after the first intra-tumoral injection.

Do I have to stop taking my current medications for the trial?

The trial requires a one-week period without corticosteroids before starting, and you must not have had systemic anti-cancer treatment within 28 days before the trial. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What makes the X-PACT treatment unique for advanced cancers?

X-PACT is unique because it combines X-ray radiation with a drug called psoralen, which is activated by the radiation to target cancer cells specifically. This dual approach aims to enhance the effectiveness of the treatment by directly attacking cancer cells while minimizing damage to surrounding healthy tissue.12345

Research Team

WE

William Eward, DVM, MD

Principal Investigator

Duke University

Eligibility Criteria

Adults over 18 with advanced head & neck cancer, breast cancer, soft tissue sarcoma or melanoma can join this trial if their tumor is superficial (less than 5 cm deep), measurable by RECIST criteria, and accessible for injection. They must have an ECOG Performance Status of ≤1, adequate organ function, no severe allergies to psoralen compounds or the phosphor device components, not be pregnant/breastfeeding and agree to use effective contraception.

Inclusion Criteria

I am 18 years old or older.
Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
My tumor can be reached for treatment either directly or with imaging guidance.
See 17 more

Exclusion Criteria

I haven't had any cancer treatments in the last 28 days or 5 half-lives, whichever is shorter.
I have a history of pancreatitis or high levels of lipase in my blood without a known cause.
I have another cancer besides the one being studied, but it's either not active or is a minor type that doesn't require treatment.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive X-PACT treatment as intra-tumoral injections over a period of 6 weeks

6 weeks
5 visits (in-person) on D1, D3, D5 of Week 1, D1 of Week 2, and D1 of Week 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years
Staging scans at baseline, day 8, week 7, and as per standard of care

Optional Booster Treatment

Eligible participants receive two additional booster treatments 4-6 weeks apart

4-6 weeks

Open-label Extension

Participants who respond to treatment may receive an additional 12 treatments over 12 months

12 months

Treatment Details

Interventions

  • X-PACT
Trial OverviewThe X-PACT treatment involves injecting a combination product into the tumor and exposing it to X-ray energy. This Phase I trial aims to establish safety through five injections over six weeks. Patients showing stable disease or response may receive two additional boosters. Safety will be determined if ≤2 out of 12 patients experience dose-limiting toxicity post-treatment.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: X-PACT TreatmentExperimental Treatment1 Intervention
Single arm consisting of a six-week treatment period with X-PACT (phosphor device and methoxsalen sterile solution and subsequently exposing the tumor to X-ray energy) administered as an intra-tumoral injection. Intra-tumoral injections will be given on D1, D3 and D5 of Week 1, on D1 of Week 2, and a booster on D1 of Week 6. After the week 8 tumor assessment subjects demonstrating stable disease, partial response or unconfirmed progression assessed by iRecist, will be eligible to receive two additional booster treatments 4-6 weeks apart.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Immunolight, LLC

Lead Sponsor

Trials
2
Recruited
20+

Findings from Research

In a study involving 30 patient-derived xenografts (PDXs) from pediatric tumors, a successful engraftment rate of 44% was observed, with factors like age over 12 years and relapsed disease linked to higher rates of engraftment.
PDX engraftment from newly diagnosed patients was found to be a significant prognostic factor for poor outcomes, particularly in standard-risk Ewing sarcoma, indicating that successful PDX models may predict a higher risk of relapse or refractory disease.
Prognostic value of patient-derived xenograft engraftment in pediatric sarcomas.Castillo-Ecija, H., Pascual-Pasto, G., Perez-Jaume, S., et al.[2023]
The study established five patient-derived xenograft (PDX) models of nasopharyngeal carcinoma (NPC) and identified significant genetic alterations, including cyclin D1 amplification and CDKN2A deletion, which are potential targets for personalized cancer therapy.
Palbociclib, a cyclin-dependent kinase inhibitor, demonstrated anti-tumor effects in NPC PDX models and showed promise in a patient with liver metastasis, leading to stable disease and a reduction in Epstein-Barr virus (EBV) levels.
Integrated genomic analyses in PDX model reveal a cyclin-dependent kinase inhibitor Palbociclib as a novel candidate drug for nasopharyngeal carcinoma.Hsu, CL., Lui, KW., Chi, LM., et al.[2022]
The R2Pulm trial found no significant difference in event-free or overall survival between patients with Ewing sarcoma treated with high-dose busulfan-melphalan chemotherapy and those receiving standard chemotherapy with whole-lung irradiation, indicating similar efficacy.
However, the BuMel treatment was associated with higher rates of severe acute toxicities, including four deaths related to treatment, suggesting that the standard VAI plus WLI approach may be safer for patients.
High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008.Dirksen, U., Brennan, B., Le Deley, MC., et al.[2022]

References

Prognostic value of patient-derived xenograft engraftment in pediatric sarcomas. [2023]
Integrated genomic analyses in PDX model reveal a cyclin-dependent kinase inhibitor Palbociclib as a novel candidate drug for nasopharyngeal carcinoma. [2022]
High-Dose Chemotherapy Compared With Standard Chemotherapy and Lung Radiation in Ewing Sarcoma With Pulmonary Metastases: Results of the European Ewing Tumour Working Initiative of National Groups, 99 Trial and EWING 2008. [2022]
Post-relapse survival in patients with Ewing sarcoma. [2022]
Establishment of Patient-Derived Tumor Xenograft Models of High-Risk Endometrial Cancer. [2019]