Phase I Study in Advanced Malignancies With 5-ALA (NCT04381806) | Clinical Trial Compass
SuspendedPhase 1
Phase I Study in Advanced Malignancies With 5-ALA
Stopped: Study drug availability
United States130 participantsStarted 2020-07-30
Plain-language summary
RDT aims to take advantage of the relatively safer toxicity profiles of both lower dose radiation therapy and systemic ALA to treat non-superficial lesions in a manner similar to photodynamic therapy. The doses of radiation administered in this study will be lower than those typically used to treat cancer. However, with administration of ALA, which has been shown to be selectively concentrated in neoplastic cells, it is reasonable to expect responses in the target lesion(s) with relative sparing of nearby normal structures. A similar therapy is currently being used in a single institution in China. Members of the Fox Chase Cancer Center have visited the Chinese medical site multiple times and have gained first-hand experience with this therapy. Based on thus-far unpublished data, this treatment appears to be both safe and well-tolerated. There have been marked responses seen in some of these patients, but this therapy has not yet been investigated in a more formalized clinical trial setting, nor has it been used on Western patients. Thus, while these findings are encouraging, much work is necessary to determine the efficacy and role of this intervention.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis:
. Patient must be a candidate for, and be willing to undergo, PET/MRI imaging
. Patients who refuse MRI imaging are not eligible
. Patients who cannot undergo PET/MRI imaging will be deemed screen failures. Rescreening X1 (once) is permissible if the investigator feels that appropriate premedications may allow successful imaging.
. 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 v5), except alopecia or parameters defined in this eligibility list
. Age ≥ 18 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Patients with symptomatic brain metastases are excluded. Patients with asymptomatic and treated 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 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).
. 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).