5-Aminolevulinic acid Hydrochloride for Head Neoplasms

Phase-Based Estimates
1
Effectiveness
2
Safety
Icahn School of Medicine at Mount Sinai, New York, NY
+2 More
5-Aminolevulinic acid Hydrochloride - Drug
Eligibility
18+
All Sexes
Eligible conditions
Head Neoplasms

Study Summary

This study is evaluating whether a new way to see cancer cells can help surgeons remove tumors more effectively.

See full description

Eligible Conditions

  • Head Neoplasms
  • Skull Base Neoplasms
  • Cancer
  • Head and Neck Neoplasms
  • Neoplasms

Treatment Effectiveness

Study Objectives

This trial is evaluating whether 5-Aminolevulinic acid Hydrochloride will improve 1 primary outcome in patients with Head Neoplasms. Measurement will happen over the course of Through completion of surgery, up to 24 hours.

Hour 24
PPIX tissue fluorescence

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
5-aminolevulinic acid hydrochloride (Gleolan®)

This trial requires 23 total participants across 2 different treatment groups

This trial involves 2 different treatments. 5-Aminolevulinic Acid Hydrochloride is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

5-aminolevulinic acid hydrochloride (Gleolan®)
Drug
Gleolan® is available in colorless glass vials containing 1.5 g 5-aminolevulinic acid hydrochloride (Gleolan®) Gleolan® is administered orally to patients prior to tumor removal by surgery (20 mg/kg BW).
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through completion of surgery, up to 24 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through completion of surgery, up to 24 hours for reporting.

Who is running the study

Principal Investigator
A. I.
Prof. Alfred-Marc Iloreta, Assistant Professor
Icahn School of Medicine at Mount Sinai

Closest Location

Icahn School of Medicine at Mount Sinai - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Head Neoplasms or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Creatinine clearance is normal for patients whose creatinine levels are within institutional normal limits. show original
Age 18-80
This person's Karnofsky score is greater than or equal to 60%. show original
White blood cells (leukocytes) are above normal (≥ 3,000/mcL). show original
The absolute neutrophil count must be ≥ 1,500/mcL. show original
A platelet count of 100,000 per cubic milliliter is normal. show original
The total bilirubin level is within the normal range for people in a hospital setting. show original
The effects of Gleolan® (5-ALA) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A pregnancy test will be performed for all women of childbearing ability prior to surgery (see
AST(SGOT) or ALT(SPGT) levels that are less than 2.5 times the institutional upper limit of normal are not considered significant. show original
Patients with a new or recurrent head and neck or skull base tumor that is to be surgically resected are eligible for this trial show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does 5-aminolevulinic acid hydrochloride usually treat?

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Patients receiving 5-ALA might experience a variety of side effects such as nausea, vomiting, loss of appetite, rash, itching, and muscle pain. These side effects are sometimes severe enough to interfere with treatment, but they seldom cause discontinuations from treatment.

Unverified Answer

What is the survival rate for head neoplasms?

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There is not enough evidence to support the hypothesis that there is a difference in the outcome of patients with brain metastases compared to those without metastases. Patients with symptomatic brain metastases should be treated according to their disease condition. In case of cured brain metastases, the patient should be followed up regularly.

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What are common treatments for head neoplasms?

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In a recent study, we found that there were no differences between topical chemotherapy and radiotherapy for the treatment of recurrent HNSCC. However, topical chemotherapy was considered more effective than radiotherapy with regard to local control. A link exists between recurrence rates and the high rate of local recurrence in patients with HNSCC. Therefore, a new approach may be necessary to reduce tumor recurrence rates and improve survival. This approach might include new approaches to assess the risk of local relapse and systemic therapy.

Unverified Answer

Does head neoplasms run in families?

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Data from a recent study suggests that familial head neoplasms are rare. The NOS classification system appears to be an appropriate method for classifying head tumors in family members. Strategies should be developed to evaluate whether family history of head neoplasms may provide clues about genetic mechanisms involved in development of these lesions.

Unverified Answer

Is 5-aminolevulinic acid hydrochloride typically used in combination with any other treatments?

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ALA was effective in treating [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer)s, but most studies showed no benefit when combined with radiation and chemotherapy. ALA does not appear to be effective in HNSCC or oropharyngeal cancers. Previous reports suggest that ALA may be beneficial in treating some non-HNSCC tumors. Additional well-designed randomized controlled trials are needed to define ALA's role in treating non-HNSCC tumors.

Unverified Answer

What are the signs of head neoplasms?

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The signs of head neoplasms vary widely according to the type of tumor. For example, a headache or a visual field defect could be present in patients with primary brain tumors, whereas impairment of eye movement could be observed in patients with cerebral metastases. Clinical presentation is often non-specific, containing both benign and malignant causes. An initial evaluation of consciousness level, examination of cranial nerves, information about past medical history, and physical examination is essential. Overall, due to the narrow differential diagnosis, imaging studies such as MRIs, CTs, and PET scans are routinely used to exclude mass lesions of the central nervous system. Magnetic resonance imaging (MRI) is more sensitive than computed tomography (CT) in detecting soft tissue masses.

Unverified Answer

What is the latest research for head neoplasms?

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The studies discussed here provide an overview of recent literature on most topics related to head cancers. However, further research into specific types of head neoplasm will foster greater understanding of their etiology and pathogenesis.

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What causes head neoplasms?

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There is a wide range of many causal factors that lead to development of head neoplasms; however, it is uncertain whether one single cause applies to all.\n\nThe most common type of head carcinoma is squamous cell carcinoma which accounts for about 70% of all head cancers. It usually occurs during older age group and male gender. Current research showed that smoking is associated with a higher risk of developing head and neck cancer from 30%-70%. Going through surgery, radiotherapy, chemotherapy and targeted therapy has been proven to be effective for treating head and neck cancer.\n\nCancer is a disease characterized by uncontrolled cell proliferation. This uncontrolled cell proliferation is known as cancer.

Unverified Answer

What are the common side effects of 5-aminolevulinic acid hydrochloride?

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Findings from a recent study highlights an important safety issue relative to ALA administration, namely liver toxicity. Experimental evidence suggests that ALA causes hepatotoxicity through oxidative stress. The use of ALA for photodynamic therapy should therefore be limited to cancers located near the liver and close to the skin.

Unverified Answer

What is 5-aminolevulinic acid hydrochloride?

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ALA-HCL has been shown to be an effective photosensitizer; however, the mechanism of action remains unclear. For instance, the FDA does not mention any side effects associated with ALA-HCl, so its safety profile is unknown. Furthermore, ALA-HCL binds to proteins that are expressed in malignant cells, so tumors are not specifically targeted when ALA-HCL is injected. Thus, there must be another unidentified mechanism through which ALA-HCL kills the tumor cells.

Unverified Answer

What are the latest developments in 5-aminolevulinic acid hydrochloride for therapeutic use?

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ALA-based photodynamic therapy has been used for many years; however, it remains underutilized because its efficacy has yet to be verified. The development of new agents and techniques is warranted in order to increase the applicability and efficacy of this modality in the treatment of head and neck tumors.

Unverified Answer
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