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5-aminolevulinic Acid In Advanced Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04443686
Recruitment Status : Recruiting
First Posted : June 23, 2020
Last Update Posted : February 16, 2021
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief Summary:
This is a phase 1, open label, dose-escalation, safety, pharmacokinetic, and pharmacodynamic study to determine the maximum tolerated doses (MTD) or recommended phase 2 doses (RP2D) of both ALA and RT. Once the MTDs are identified, the cohort providing the highest dose intensity at or below the MTD (if supported by emerging PK and biomarker data) will be selected for an expansion phase for the purpose of refining the safety assessment and assessing preliminary efficacy. The initial dose escalation phase will enroll at least 20 patients across a variety of tumor types, after which concurrent disease site-specific expansion cohorts will accrue, each consisting of 20 patients. Anatomic site-specific cohorts will include patients with symptomatic metastatic disease to specific anatomic regions, where varying toxicity may be expected (Head and Neck, Thorax and Abdomen/Pelvis).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: Low dose radiation and ALA Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Dose Escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Finding Study Of Low-dose Radiation With Sensitization Using 5-aminolevulinic Acid In Advanced Malignancies
Actual Study Start Date : July 30, 2020
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2027

Arm Intervention/treatment
Experimental: ALA / Fractions of Radiotherapy
Subjects will receive 3 doses of ALA and fractions of radiation therapy during the course of one 21day cycle. Only one cycle per patient is allowed.
Drug: Low dose radiation and ALA
Patients will be seen in the CRU and administered ALA on day 1, 8, and 15. Open-field radiotherapy and targeted-field radiotherapy will be given on days 1, 8, and 15
Other Name: Radiation

Primary Outcome Measures :
  1. Max tolerated dose (MTD) of ALA and radiation [ Time Frame: 56 days ]
    Determine the MTD of ALA and radiotherapy when administered concurrently

Secondary Outcome Measures :
  1. Evaluation of adverse events and laboratory abnormalities [ Time Frame: 56 days ]
    Overall safety profile of ALA with RT as characterized by type, frequency, severity, timing and relationship to study therapy of adverse events (AEs) and laboratory abnormalities as per CTCAE v5.0

  2. Response rate [ Time Frame: 1 year ]
    Objective tumor response, as assessed using the Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1 in patients with measurable disease

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis:

    1. Patients must have a histologically and/or cytologically confirmed primary solid tumors
    2. Lesion(s) of interest (target or non-target) must be evaluable by PET or MRI
    3. Radiographic or clinical evidence of advanced/metastatic disease that is:

    i. Resistant to standard therapy or for which no standard therapy is available.

  2. Patient must be a candidate for, and be willing to undergo, PET/MRI imaging

    1. Patients who refuse MRI imaging are not eligible
    2. 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.
  3. 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

    a. Patients previously treated with a bleomycin regimen are not permitted to undergo radiation therapy to the thorax

  4. Age ≥ 18 years
  5. ECOG performance status ≤ 2
  6. Systolic blood pressure ≥ 110 mmHg and diastolic blood pressure ≥ 70 mmHg
  7. Adequate organ and marrow function as defined below:

    1. Absolute neutrophil Count ≥1,000/mm3 without growth factor use ≤ 7 days prior to C1D1
    2. Platelets ≥75,000/mm3 without platelet transfusion ≤ 7 days prior to C1D1
    3. Hemoglobin >8.0 mg/dL without red blood cell transfusion ≤ 7 days prior to C1D1
    4. Total serum bilirubin <1.5 X upper limit of normal (ULN)
    5. AST (SGOT)/ALT (SGPT) ≤2 X ULN
    6. Serum creatinine ≤ 1.5 X ULN AND Creatinine clearance (per eGFR) ≥ 40 mL/min/1.73 m2)
  8. Serum pregnancy test (for females of childbearing potential) negative within ≤7 days of C1D1
  9. 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.
  10. 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.

Exclusion Criteria:

  • 1. 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.

    2. 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.

    3. Current active treatment in another therapeutic clinical study 4. 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).

    a. 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) 5. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)- related illness (testing is not required for eligibility) 6. Patients undergoing phototherapy for another, non-oncologic or oncologic disease (e.g. PUVA therapy or photodynamic therapy for skin diseases) 7. 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.

    8. Patients with a known history of porphyria (testing for porphyria is not required to participate).

    9. 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.

    10. 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.

    11. Pregnant or breast-feeding patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04443686

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Contact: Anthony Olszanski, MD 2152141676
Contact: Thomas Galloway, MD 2157285536

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United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Anthony Olszanski, MD    215-214-1676   
Principal Investigator: Anthony Olszanski, MD         
Sponsors and Collaborators
Fox Chase Cancer Center
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Responsible Party: Fox Chase Cancer Center Identifier: NCT04443686    
Other Study ID Numbers: 20-1009
RT-90 ( Other Identifier: FCCC ISRU )
First Posted: June 23, 2020    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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