Low-dose Radiation and Aminolevulinic Acid for the Treatment of Advanced or Metastatic Solid Tumors

Inclusion Criteria

• Patients must have a histologically and/or cytologically confirmed primary solid tumors
• Radiographic or clinical evidence of advanced/metastatic disease that is: * Resistant to standard therapy or for which no standard therapy is available
• All patients must have at least one gross tumor volume (GTV). Multiple GTVs are allowed within the total field size not to exceed 20 x 20 cm
• All previous therapies for cancer, including radiotherapy, major surgery, and/or investigational therapies, must be discontinued for >= 14 days (>= 28 days for mitomycin C or nitrosoureas) before the treatment date, and all acute effects of any prior therapy must have resolved to baseline severity or grade =< 1 Common Terminology Criteria for Adverse Events (CTCAE version [v]5), except alopecia or parameters defined in this eligibility list * Patients previously treated with a bleomycin regimen are not permitted to undergo radiation therapy to the thorax
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2
• Systolic blood pressure >= 110 mmHg and diastolic blood pressure >= 70 mmHg
• Absolute neutrophil count >= 1,000/mm^3 without growth factor use =< 7 days prior to cycle 1 day 1 (C1D1)
• Platelets >= 75,000/mm^3 without platelet transfusion =< 7 days prior to C1D1
• Hemoglobin >= 8.0 mg/dL without red blood cell transfusion =< 7 days prior to C1D1
• Total serum bilirubin =< 1.5 X upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 X ULN
• Serum creatinine =< 1.5 X ULN AND Creatinine clearance (per estimated glomerular filtration rate [eGFR]) >= 40 mL/min/1.73 m^2)
• Serum pregnancy test (for females of childbearing potential) negative within =< 7 days of C1D1
• Ability to understand and the willingness to sign a written informed consent document and comply with the study scheduled visits, treatment plans, laboratory tests and other procedures
• Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator or a designated associate
• Consent to 48- hour dim light exposure after each dosing of ALA

Exclusion Criteria

• Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and/or treated central nervous system (CNS) metastases may participate in this trial. The patient must have completed any prior treatment for CNS metastases >= 28 days prior to study entry, including radiotherapy or surgery. Steroids for the treatment of symptoms of brain metastasis are not permitted
• Patients with active seizures are not permitted. Anti-seizure medications are permitted. However, to meet eligibility, patients must not have had a seizure within 28 days of C1D1
• Patients must be able to take enterally-administered medications. Patients must not have any clinical evidence of impaired gastrointestinal function or any gastrointestinal disease that may significantly alter the absorption of ALA, in the opinion of the treating investigator. Patients who cannot swallow but rely on enterally- administered supplementation may enroll if they otherwise meet this criterion
• Current active treatment in another therapeutic clinical study
• Active bacterial, fungal or viral infection, including hepatitis B (HBV) or hepatitis C (HCV), requiring treatment with intravenous antibiotic, anti-fungal, or anti-viral medications (testing is not required for eligibility) * Patients may be enrolled while undergoing treatment for trivial infections with oral agents (e.g. superficial skin infections, uncomplicated urinary tract infections, candidal oral/vaginal infections, conjunctivitis, etc) * Agents known to be associated with photosensitivity (e.g. quinolones) should be avoided
• Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (testing is not required for eligibility)
• Patients undergoing phototherapy for another, non-oncologic or oncologic disease (e.g. PUVA therapy or photodynamic therapy for skin diseases)
• Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism
• Patients with a known history of porphyria (testing for porphyria is not required to participate)
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or in the judgment of the investigator would make the patient inappropriate for entry into the study
• Patients with implanted battery-controlled devices (including, but not limited to, pacemakers and implanted cardiovascular defibrillator [AICDs]) that may suffer interference from neutron contamination of high energy photon beams. * Patients who meet this exclusion criterion will be reviewed with radiation oncology to determine if the device poses a risk. Radiation oncology has the prerogative to allow a patient on study if there is no risk
• Pregnant or breast-feeding patients