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

Eligibility 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
• * oral
• * intravaginal
• * transdermal
• * progestogen-only hormonal contraception associated with inhibition of ovulation
• * 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 also be considered.
• 12. As determined by the enrolling physician, ability of the patient to understand and comply with study procedures for the entire length of the study
• 13. Patient is expected to have a life expectancy of at least 4 months
• 14. If the proposed site of treatment with X-PACT had prior exposure to curative-intent radiation, the patient may be entered into the trial with the following provisions satisfied.
• * 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.
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