Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)

NCT06252727 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 2074423
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a prospective pilot study that will evaluate 20 patients who were diagnosed with FNCLCC Grade 2 or 3 soft tissue sarcomas and will undergo surgical resection. Based upon the FDA label, successful protocols used for intraoperative fluorescence-guided visualization for glioma resections, and on drug company current dosing recommendation for this study, patients will be administered 20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to surgery. The use of 5-ALA fluorescence will be relevant for evaluating the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.

Conditions

Soft Tissue Sarcoma; Soft Tissue Sarcoma Adult

Outcome Measures

Primary Outcomes (1)

• Feasibility of 5-ALA-aided fluorescent visualization of STS versus surrounding tissues

  Ability of 5-ALA to provide intraoperative fluorescent visualization of STS versus surrounding tissues as assessed by the fluorescence of the surgical bed and hemisected soft tissue sarcoma (STS) after resection. This will be assessed during the surgical procedure and recorded via imaging and videography to analyze fluorescent visualization

  Up to 2 years

Secondary Outcomes (3)

• Efficacy of tumor and surgical margin resections by a gross and histological analysis of fluorescing and non-fluorescing samples immediately after removal.

  Up to 2 years

• Disease free survival.

  Up to 2 years

• Incidence of treatment related adverse events.

  Up to 2 years

Study Arms (1)

Aminolevulinic acid (5-ALA)

EXPERIMENTAL

20 mg/kg body weight of 5-ALA orally at 3-4 hours prior to surgical resection. 5-ALA fluorescence will be used to evaluate the resected tumor per gross margins and identifying further areas of fluorescing tissues beyond the gross tumor margins.

Drug: Aminolevulinic Acid

Interventions

Aminolevulinic Acid DRUG

Given PO

Also known as: 5-ALA, Gleolan

Aminolevulinic acid (5-ALA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological confirmation of any subtype of primary Grades 2 or 3 soft tissue sarcomas (STS), per biopsy evaluation by a pathologist, according to Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC).
• Treatment decision includes planned surgical resection of STS.
• Age ≥18 years at time of consent.
• ECOG Performance Status 0 - 1 (see Appendix)
• Hematology and blood chemistry parameters defined by:
• Leukocytes ≥ 3 × 109/L
• Absolute neutrophil count ≥ 1.5 × 109/L
• Platelets ≥ 100 × 109/L, transfusions may be used to raise platelets to ≥ 100 × 109/L (no washout required)
• Hemoglobin ≥ 9 g/dL, transfusions may be used to raise Hgb to ≥ 9 g/dL (no washout required)
• Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)
• Aspartate transaminase (AST) / alanine transaminase (ALT) ≤ 2.5 × institutional ULN
• Creatinine within normal institutional limits OR creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine above institutional ULN
• Participants of reproductive potential must agree to using adequate contraception (e.g., hormonal or barrier method of birth control; abstinence, an intrauterine device) for the duration of study participation (including dosing interruptions) and up to 42 days after end of study intervention; or be surgically sterilized (e.g., hysterectomy, tubal ligation, or vasectomy).
• Ability to swallow study agent.
• Ability to understand and willingness to sign an informed consent form.

You may not qualify if:

• Acute/chronic forms of porphyria.
• Uncontrolled, known concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness.
• Patient has had chemotherapy, tumor resection, or radiation treatment ≤ 21 days prior to surgery.
• Simultaneous participation in another clinical trial ≤ 21 days of enrollment or during the duration of the study period.
• Planned use of other potentially phototoxic substances (e.g., St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulfonamides, quinolones and tetracyclines), and topical preparations containing aminolevulinic acid (5-ALA) for 24 hours during the perioperative period (defined as 24 hours prior to surgery to up to 24 hours post surgery).
• Pregnant or planning to become pregnant during study participation or breastfeeding.
• Any condition that in the opinion of the investigator would prohibit the understanding or rendering of informed consent or interfere with the participant's safety or compliance while on trial.

Sponsors & Collaborators

• University of California, Davis: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95827, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Steven W Thorpe, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: July 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

US (1)