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New treatment option for Advanced Solid Tumor Cancer
Official title X-ray Psoralen Activated Cancer Therapy in Head and Neck, Breast, Sarcoma and Melanoma
ClinicalTrials.gov ID: NCT04389281
What this study is testing
What is X-PACT?
X-PACT is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced solid tumor cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the...
- Age ≥ 18 years at the time of consent
- ECOG Performance Status of ≤ 1
- people with histologically or cytologically confirmed advanced solid tumors which have progressed after standard therapy(ies), intolerant to standard...
- A non-visceral tumor, a metastatic lymph node, a metastasis from a visceral solid tumor provided the lesion is extravisceral, or a cutaneous tumor...
You likely can't join if
- Exclusion Criteria:
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
- Prior exposure to methoxsalen
- History of any of the following: a. Idiosyncratic or hypersensitivity reactions to any psoralen compounds or any of their excipients b. Light...
- History of idiosyncratic or hypersensitivity reactions to any of the phosphor device components
- Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection (NOTE: testing not required)
See the full eligibility criteria
Who can join
- 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.
- Age ≥ 18 years at the time of consent
- ECOG Performance Status of ≤ 1
- people 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...
- 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.
- The tumor must be measurable as per RECIST criteria.
- The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance.
- The tumor identified for injection should be selected so local control could potentially provide benefit to the patient.
- 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician)
- The tumor must be superficial and not exceed a depth of 5 cm.
- Eye or brain tumors will not be treated.
- 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...
- 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...
- 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.
- Demonstrate adequate organ function as defined in the table below: Hematological: White blood cell (WBC) ≥ 3 x 109/L Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L Platelet Count ≥ 100 x 109/L Hemoglobin (Hgb) ≥ 8 g/dL2...
- 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...
- 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...
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation o oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation o oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- vasectomised partner
- sexual abstinence 11\. Male patients must be willing to use condoms from the time of informed consent until 28 days after treatment discontinuation. For a non-pregnant FCBP partner, contraception recommendations should...
- 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...
What rules you out
- Exclusion Criteria:
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study.)
- Prior exposure to methoxsalen
- History of any of the following: a. Idiosyncratic or hypersensitivity reactions to any psoralen compounds or any of their excipients b. Light sensitive disease state c. Disease associated with photosensitivity including...
- History of idiosyncratic or hypersensitivity reactions to any of the phosphor device components
- Known diagnosis of human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection (NOTE: testing not required)
- Active infection requiring systemic therapy (NOTE: at discretion of investigator, patients with uncomplicated urinary tract infections may be eligible.)
- Has a known additional other primary malignancy that is active and/or progressive requiring treatment; exceptions include basal cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the patient...
- Systemic anti-cancer treatment within 28 days (or 5 half-lives, whichever is shorter) prior to day 1 of treatment
- Treatment with any investigational drug within 5 half-lives or 28 days, whichever is shorter (or if half-life is unknown, within 28 days) prior to day 1 of treatment
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following: a. Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded) b...
- Other uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements as determined by the...
- The tumor identified for treatment has a volume greater than 500 cc (Soft Tissue Sarcoma only). All other tumor types may have a maximum volume of 300 cc
- Receiving or planned use of corticosteroids. people will require a one-week washout period from prior corticosteroid use. Inhaled or topical steroids are permitted.
- people with active autoimmune disease requiring 10 mg or greater of prednisone and/or biologic agents.
- people with a history of pancreatitis or elevated baseline serum lipase without otherwise specified etiology. For the Expansion Cohorts, the inclusion criteria remain the same except for Inclusion Criteria #4 and #14...
- 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.
- The tumor must be measurable as per RECIST criteria, at least 1 cm for masses and 1.5 cm for lymph nodes.
- The tumor should be directly accessible for injection or accessible with the use of ultrasound/CT guidance.
- 80% of the tumor must be accessible for injection with X-PACT (assessed by the treating physician)
- Up to 4 target lesions may be selected for injection in up to two radiation fields, but the radiation fields may not overlap, however, the total phosphors delivered may not exceed 840 mg for each treatment day (e.g...
- For the TNBC Cohort, participants must have either unresectable, locally advanced, relapsed, refractory or metastatic disease with HER2 negative/low ER/PR status (\<10%) or HER2 negative/ER/PR negative. Patients...
- For the STS Cohort, participants must have received at least one prior treatment (best medical treatment recommended for the participants sub-type) for unresectable, locally advanced, relapsed, refractory or metastatic...
- 14 It is preferable to select tumors that have not been previously radiated, but if other options are not available and the tumor selected is in a field which received curative-intent radiation, then the participant may...
- 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, has assessed the cumulative...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Greenville, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Charlotte, North Carolina, United States; Durham, North Carolina, United States; Greenville, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.