What side effects are associated with this type of intervention?

Common side effects of treatments for Adenoid Cystic Carcinoma, particularly those similar to Lenvatinib, include hypertension, diarrhea, weight loss, proteinuria, and palmar-plantar erythrodysesthesia syndrome. Other potential side effects are fatigue, mucositis, anorexia, and arterial hypertension. These side effects necessitate careful management to maintain the patient's quality of life.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Adenoid Cystic Carcinoma (ACC) mentioned in the provided context. However, Lenvatinib, an oral medication with anti-proliferative and anti-angiogenic properties, is currently being studied for its efficacy in treating ACC. This drug interferes with cancer cell growth and reduces the growth of blood vessels around tumors, which is a promising approach for managing ACC.

What other types of research exist?

Promising alternatives to Lenvatinib for Adenoid Cystic Carcinoma patients include Bevacizumab, which targets VEGF and has shown some efficacy in highly vascular tumors, and Everolimus, an mTOR inhibitor that has demonstrated tumor burden reduction in other cancers. Additionally, investigational agents like the NOTCH inhibitor AL101 are being evaluated in clinical trials for ACC and may offer novel therapeutic options.

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Tyrosine Kinase Inhibitor

Lenvatinib for Adenoid Cystic Carcinoma

Phase 2

Waitlist Available

Led By Alan Ho, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Platelet count ≥ 100,000 /mm3, hemoglobin (Hb) ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm3. Blood transfusion to meet the inclusion criteria will not be allowed.

Subject must be able to swallow and retain oral medication.

Must not have

Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of study treatment start.

Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing lenvatinib, a pill that aims to stop cancer cells from growing and reduce their blood supply, in patients with adenoid cystic carcinoma. Researchers want to see if it can shrink the tumors by at least one-quarter. Lenvatinib has shown promise in treating various solid tumors, including adenoid cystic carcinoma.

Who is the study for?

Adults with measurable adenoid cystic carcinoma, good performance status, and proper organ function can join. They must have tried other treatments without success and not used lenvatinib before. Participants need available tumor tissue for study, no recent major surgeries or bleeding events, stable blood pressure without severe medication, and agree to use contraception.

What is being tested?

The trial is testing the effects of an oral drug called Lenvatinib on shrinking adenoid cystic carcinoma tumors by at least one-quarter. It's a phase II study to see if this drug can slow down cancer growth by disrupting the cancer cells' functions and cutting off their blood supply.

What are the potential side effects?

Lenvatinib may cause high blood pressure, fatigue, nausea, decreased appetite, kidney problems like protein in urine or failure requiring dialysis; it might also lead to serious cardiac conditions or increase the risk of bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood counts meet the required levels without transfusions.

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I can swallow and keep down pills.

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I can take care of myself but might not be able to do heavy physical work.

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I have a tumor that can be measured with a scan.

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My cancer has returned or spread and cannot be removed by surgery or cured with radiation.

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I am 18 years old or older.

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My kidney function is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had a stroke, clot, or embolism in the last 6 months.

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I haven't had major surgery or a serious injury in the last 28 days.

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My high blood pressure is not controlled even with medication.

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My urine protein levels are below 1 g/24-hour.

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I have serious heart problems, including recent heart attacks or unstable chest pain.

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I do not have an infection that would stop me from receiving the study treatment.

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I have a wound or ulcer that hasn’t healed, but it’s not caused by cancer.

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I have not had severe bleeding in the last 4 weeks.

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I have a condition that affects how my body absorbs nutrients.

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I am not pregnant or breast-feeding.

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I have a history of bleeding disorders.

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I currently have symptoms of interstitial lung disease.

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I have HIV or hepatitis B/C that needs antiviral treatment.

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I am on medication for seizures.

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I have had an organ transplant.

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I require dialysis for kidney failure.

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I have previously taken lenvatinib.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

best overall response rate (BOR)

Side effects data

From 2019 Phase 3 trial • 392 Patients • NCT01321554

70%

Diarrhoea

69%

Hypertension

57%

Decreased appetite

54%

Weight decreased

49%

Nausea

44%

Fatigue

40%

Headache

38%

Proteinuria

38%

Vomiting

38%

Stomatitis

33%

Palmar-plantar erythrodysaesthesia syndrome

33%

Arthralgia

33%

Dysphonia

32%

Constipation

30%

Cough

26%

Asthenia

25%

Oedema peripheral

21%

Rash

20%

Back pain

20%

Myalgia

19%

Abdominal pain

18%

Abdominal pain upper

18%

Pain in extremity

18%

Dysgeusia

18%

Musculoskeletal pain

18%

Dry mouth

18%

Dyspnoea

17%

Dizziness

16%

Pyrexia

16%

Oropharyngeal pain

16%

Hypokalaemia

15%

Dyspepsia

15%

Hypocalcaemia

14%

Epistaxis

13%

Dysphagia

13%

Alopecia

12%

Anaemia

12%

Musculoskeletal chest pain

12%

Dry skin

11%

Urinary tract infection

11%

Nasopharyngitis

10%

Hypoalbuminaemia

10%

Thrombocytopenia

10%

Oral pain

10%

Blood creatinine increased

10%

Electrocardiogram QT prolonged

10%

Upper respiratory tract infection

Dehydration

Neck pain

Depression

Hypomagnesaemia

Influenza like illness

Muscle spasms

Lymphopenia

Alanine aminotransferase increased

Muscular weakness

Malaise

Haematuria

Ejection fraction decreased

Pruritus

Hyponatraemia

Blood thyroid stimulating hormone increased

Platelet count decreased

Aspartate aminotransferase increased

Toothache

Glossodynia

Blood alkaline phosphatase increased

Hyperkeratosis

Bronchitis

Flatulence

Influenza

Dysuria

Anxiety

Hyperglycaemia

Leukopenia

Non-cardiac chest pain

Productive cough

Paraesthesia

Hypothyroidism

Haemoptysis

White blood cell count decreased

Pneumonia

General physical health deterioration

Sepsis

Cholecystitis

Pulmonary embolism

Malignant pleural effusion

seizure

Acute myocardial infarction

Atrial fibrillation

Lower respiratory tract infection

Hypotension

Lung infection

Spinal cord compression

Acute kidney injury

Blood uric acid increased

Monoparesis

Acute respiratory failure

Hypercalcaemia

Hepatic failure

Acute coronary syndrome

Appendicitis

Death

Respiratory failure

Osteoarthritis

Intestinal obstruction

Small intestinal obstruction

Intracranial tumour haemorrhage

Colitis

Transient ischaemic attack

Pancreatitis

Atrial flutter

Cardio-respiratory arrest

Uterine prolapse

Coronary artery stenosis

Pneumatosis intestinalis

Cerebrovascular accident

Confusional state

Liver injury

Diverticulitis

Bacteraemia

Gastroenteritis

Perineal abscess

Wound infection

Malignant neoplasm progression

Bone pain

Cancer pain

Syncope

Vocal cord paralysis

Nephrotic syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Randomization Phase: Lenvatinib 24 mg

Randomization Phase: Placebo

OOL, Treatment Period: Lenvatinib 24 mg

OOL, Treatment Period: Lenvatinib 20 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LenvatinibExperimental Treatment1 Intervention

All eligible patients will receive a starting lenvatinib dose of 24 mg daily taken orally for each 4-week cycle. Patients may remain on study until progression of disease or unacceptable toxicity. Alternatively, Lenvatinib may be dissolved in fluid per the Food and Drug Administration (FDA) label and administered orally or via a feeding tube.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib

2017

Completed Phase 4

~2070

0 / 24Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Adenoid Cystic Carcinoma (ACC) often include anti-proliferative and anti-angiogenic agents like Lenvatinib. These treatments work by inhibiting the growth of cancer cells and reducing the formation of new blood vessels that supply the tumor. Specifically, Lenvatinib targets multiple receptor tyrosine kinases involved in tumor proliferation and angiogenesis. This dual mechanism is particularly important for ACC patients as it can help to control tumor growth and spread, providing a valuable treatment option for a cancer that is typically resistant to standard therapies.

Surgical treatment of a rare case of hepatocellular carcinoma with right atrial metastasis: A case report.Surgical treatment of locally advanced papillary thyroid carcinoma after response to lenvatinib: A case report.