RECRUITING

X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma

Conditions

Advanced Solid Tumor Cancer Advanced Head & Neck Cancer Advanced Breast Cancer Advanced Melanoma Advanced Soft Tissue Sarcoma Advanced Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Two expansion cohorts have been added to the study. One for TNBC and one for soft tissue sarcoma. 16 additional subjects will be added in each of the expansion cohorts.

Official Title

Phase 1 Study of X-PACT (X-ray Psoralen Activated Cancer Therapy) for Intra-tumoral Injection of Superficial Tumors in Patients With Advanced Head and Neck Cancer, Breast Cancer, Soft Tissue Sarcoma or Melanoma

Quick Facts

Study Start:2021-12-08

Study Completion:2029-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04389281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. Age ≥ 18 years at the time of consent 3. ECOG Performance Status of ≤ 1 4. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed after standard therapy(ies), intolerant to standard therapy, refused standard therapy or for which no standard therapy(ies) exist. Furthermore, the tumor targeted for injections should be: 1. A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated. 2. The tumor must be measurable as per RECIST criteria. 3. The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance. 4. The tumor identified for injection should be selected so local control could potentially provide benefit to the patient. 5. 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician) 6. The tumor must be superficial and not exceed a depth of 5 cm. 7. Eye or brain tumors will not be treated. 5. A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to day 1 of treatment, have been off of corticosteroids for ≥ 2 weeks, and brain metastases are asymptomatic. 6. The study site Radiation Oncologist Investigator/sub-investigator has determined additiional radiation delivered via X-PACT is appropriate given patient's prior radiation exposure. The treating Radiation Oncologist will review all prior radiation received to the proposed site of X-PACT treatment and assess the potential for unacceptable toxicity to the site or local organ(s) using QUANTEC. 7. All toxicities from prior therapy should be ≤Grade 1 before start of study treatment. All radiation associated toxicities must have completely resolved to be considered for inclusion into the study. 8. Demonstrate adequate organ function as defined in the table below: 9. Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 3 days prior to day 1 of treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause). 10. FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of informed consent until 28 days after treatment discontinuation. Contraceptive methods with low user dependency are preferable but not required (see table below, adapted from: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation * intravaginal * transdermal * progestogen-only hormonal contraception associated with inhibition of ovulation * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system (IUS) * vasectomised partner * sexual abstinence * There is at least a 6 month wash out period from the last date radiation was received to assess for radiation toxicity. * If there was previous radiation toxicity at the proposed site of X-PACT, the toxicity resolved at least three months ago and the site did not involve a major organ. * The site investigator in addition to the radiation oncologist (as a part of criterion #6) has fully reviewed the subject's radiation history, has examined the area for radiation toxicity and assessed the cumulative dose for either 5 or 7 X-PACT treatments and determined they will not pose additional risk for radiation toxicity or re-activate any other previous toxicity.	*

Inclusion Criteria

Exclusion Criteria

1. 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.
2. Age ≥ 18 years at the time of consent
3. ECOG Performance Status of ≤ 1
4. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed after standard therapy(ies), intolerant to standard therapy, refused standard therapy or for which no standard therapy(ies) exist. Furthermore, the tumor targeted for injections should be:
1. A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor. Visceral tumors will not be treated.
2. The tumor must be measurable as per RECIST criteria.
3. The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance.
4. The tumor identified for injection should be selected so local control could potentially provide benefit to the patient.
5. 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician)
6. The tumor must be superficial and not exceed a depth of 5 cm.
7. Eye or brain tumors will not be treated.
5. A patient with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to day 1 of treatment, have been off of corticosteroids for ≥ 2 weeks, and brain metastases are asymptomatic.
6. The study site Radiation Oncologist Investigator/sub-investigator has determined additiional radiation delivered via X-PACT is appropriate given patient's prior radiation exposure. The treating Radiation Oncologist will review all prior radiation received to the proposed site of X-PACT treatment and assess the potential for unacceptable toxicity to the site or local organ(s) using QUANTEC.
7. All toxicities from prior therapy should be ≤Grade 1 before start of study treatment. All radiation associated toxicities must have completely resolved to be considered for inclusion into the study.
8. Demonstrate adequate organ function as defined in the table below:
9. Females of childbearing potential (FCBP) must have a negative serum pregnancy test within 3 days prior to day 1 of treatment. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (at least 12 consecutive months with no menses without an alternative medical cause).
10. FCBP must be willing to use a highly effective contraceptive method (i.e., achieves a failure rate of \<1% per year when used consistently and correctly) from the time of informed consent until 28 days after treatment discontinuation. Contraceptive methods with low user dependency are preferable but not required (see table below, adapted from:
* combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
* intravaginal
* transdermal
* progestogen-only hormonal contraception associated with inhibition of ovulation
* injectable
* implantable
* intrauterine device (IUD)
* intrauterine hormone-releasing system (IUS)
* vasectomised partner
* sexual abstinence
* There is at least a 6 month wash out period from the last date radiation was received to assess for radiation toxicity.
* If there was previous radiation toxicity at the proposed site of X-PACT, the toxicity resolved at least three months ago and the site did not involve a major organ.
* The site investigator in addition to the radiation oncologist (as a part of criterion #6) has fully reviewed the subject's radiation history, has examined the area for radiation toxicity and assessed the cumulative dose for either 5 or 7 X-PACT treatments and determined they will not pose additional risk for radiation toxicity or re-activate any other previous toxicity.

Contacts and Locations

Study Contact

Susan N McLaughlin, BSN

CONTACT

7048776363

smclaughlin@immunolight.com

Lauren Wood, MD

CONTACT

6788995225

Principal Investigator

William Eward, MD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Sibley Hospital - Johns Hopkins University

Washington D.C., District of Columbia, 20016

United States

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Duke University

Durham, North Carolina, 27710

United States

Prisma Health

Greenville, South Carolina, 29605

United States

Collaborators and Investigators

Sponsor: Immunolight, LLC

William Eward, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-08

Study Completion Date2029-03

Study Record Updates

Study Start Date2021-12-08

Study Completion Date2029-03

Terms related to this study

Keywords Provided by Researchers

Advanced Head & Neck Cancer
Advanced Breast Cancer
Advanced Melanoma
Advanced Soft Tissue Sarcoma
Advanced Solid Tumor

Additional Relevant MeSH Terms

Advanced Solid Tumor Cancer