Ruxolitinib for Carcinoma, Squamous Cell

Phase-Based Estimates
1
Effectiveness
2
Safety
Columbia University Irving Medical Center, New York, NY
Carcinoma, Squamous Cell+2 More
Ruxolitinib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Squamous Cell

Study Summary

This study is evaluating whether a drug may help treat skin cancer.

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Eligible Conditions

  • Carcinoma, Squamous Cell
  • Carcinoma
  • Advanced Cutaneous Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Ruxolitinib will improve 1 primary outcome and 2 secondary outcomes in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of within the first 24 weeks of the start of study therapy.

Up to 36 months
Overall Survival (OS)
Progression-Free Survival (PFS)
Week 24
Overall Response Rate (ORR)

Trial Safety

Safety Estimate

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

Compared to trials

Side Effects for

Best Available Therapy
Pruritus
23%
Headache
12%
Diarrhoea
9%
Upper respiratory tract infection
9%
Thrombocytopenia
8%
Asthenia
8%
Fatigue
8%
Nausea
7%
Dizziness
7%
Night sweats
7%
Haematocrit increased
7%
Decreased appetite
5%
Weight decreased
5%
Erythema
5%
Influenza
5%
Leukocytosis
5%
Constipation
5%
Arthralgia
4%
Abdominal pain upper
4%
Hypertension
4%
Thrombocytosis
4%
Tinnitus
3%
Dyspnoea
3%
Epistaxis
3%
Abdominal discomfort
3%
Myalgia
3%
Cough
3%
Dyspepsia
3%
Oedema peripheral
3%
Nasopharyngitis
3%
Pain in extremity
3%
Bronchitis
3%
Gamma-glutamyltransferase increased
1%
Rectal haemorrhage
1%
Flatulence
1%
Hyponatraemia
1%
Abdominal pain
1%
Blood lactate dehydrogenase increased
1%
Hyperuricaemia
1%
Osteoarthritis
1%
Anaemia
1%
Atrial fibrillation
1%
Syncope
1%
Pyrexia
1%
Septic shock
1%
Vertigo
1%
Depression
1%
Gastrointestinal haemorrhage
1%
Meningitis
1%
Extremity necrosis
1%
Cellulitis
1%
Musculoskeletal pain
1%
Haematoma
1%
Pneumonia
1%
Neutropenia
1%
Bladder transitional cell carcinoma
1%
Myelofibrosis
1%
Respiratory failure
1%
Abdominal distension
1%
Vomiting
1%
Weight increased
1%
Muscle spasms
1%
Acute myeloid leukaemia
1%
Breast cancer
1%
Cardiac failure
1%
Renal failure
1%
Myocardial infarction
0%
Peripheral artery occlusion
0%
Localised infection
0%
Vertigo positional
0%
Pyonephrosis
0%
Sinusitis
0%
Cardiac disorder
0%
Ulna fracture
0%
Spinal fracture
0%
Herpes zoster
0%
Metastatic malignant melanoma
0%
Back pain
0%
Bone pain
0%
Vision blurred
0%
Tendon rupture
0%
Blood uric acid increased
0%
Dehydration
0%
Diabetes mellitus
0%
Blood creatine phosphokinase increased
0%
Gastrointestinal inflammation
0%
Mitral valve incompetence
0%
Pyelonephritis
0%
Skin ulcer
0%
Parathyroid tumour benign
0%
Non-cardiac chest pain
0%
Non-small cell lung cancer metastatic
0%
Blue toe syndrome
0%
Pulmonary embolism
0%
Acute pulmonary oedema
0%
Visual acuity reduced
0%
Pericardial effusion
0%
Lumbar vertebral fracture
0%
Radius fracture
0%
Hyperleukocytosis
0%
Inguinal hernia
0%
Carcinoma in situ
0%
Hypoxia
0%
Dyslipidaemia
0%
Osteoporosis
0%
Hypercholesterolaemia
0%
Cognitive disorder
0%
Juvenile melanoma benign
0%
Hypertriglyceridaemia
0%
Intervertebral disc protrusion
0%
Paraesthesia
0%
Urosepsis
0%
Foot deformity
0%
Cystitis
0%
Basal cell carcinoma
0%
Post procedural haemorrhage
0%
Cholelithiasis
0%
Bowen's disease
0%
Neuropathy peripheral
0%
Blast cell crisis
0%
Vaginal cancer
0%
Facial neuralgia
0%
Gastrooesophageal reflux disease
0%
Blood creatinine increased
0%
Muscle rupture
0%
Small intestinal obstruction
0%
Hip fracture
0%
Angina pectoris
0%
Coronary artery disease
0%
Oesophageal varices haemorrhage
0%
Lower respiratory tract infection
0%
Respiratory tract infection
0%
Haemarthrosis
0%
Basosquamous carcinoma of skin
0%
Bone marrow tumour cell infiltration
0%
Lung adenocarcinoma
0%
Metastases to spine
0%
Prostate cancer
0%
Prostatic adenoma
0%
Acute myocardial infarction
0%
Aortic valve incompetence
0%
Ophthalmic herpes zoster
0%
Squamous cell carcinoma of skin
0%
Uterine neoplasm
0%
Glaucoma
0%
Cerebrovascular accident
0%
Epilepsy
0%
General physical health deterioration
0%
Sepsis
0%
Urinary tract infection
0%
Haematuria
0%
Skin cancer
0%
Ischaemic stroke
0%
Ureterolithiasis
0%
Memory impairment
0%
Actinic keratosis
0%
Dyspnoea exertional
0%
Venous haemorrhage
0%
Renal cancer
0%
Nephrolithiasis
0%
Urethral stenosis
0%
Peripheral arterial occlusive disease
0%
Peripheral artery thrombosis
0%
Retinal artery occlusion
0%
This histogram enumerates side effects from a completed 2020 Phase 3 trial (NCT02038036) in the Best Available Therapy ARM group. Side effects include: Pruritus with 23%, Headache with 12%, Diarrhoea with 9%, Upper respiratory tract infection with 9%, Thrombocytopenia with 8%.

Trial Design

2 Treatment Groups

Control
Ruxolitinib

This trial requires 35 total participants across 2 different treatment groups

This trial involves 2 different treatments. Ruxolitinib 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.

Ruxolitinib
Drug
In a safety lead-in of 6 patients, subjects will receive 15mg of ruxolitinib twice daily (BID). After 4 weeks, if dose-limiting toxicities (DLT) are observed in 1 or fewer patients, the study will enter stage 1 of the Simon two-stage design where all subsequent patients will receive a starting dose of ruxolitinib 15mg BID. Subjects will have regularly scheduled study visits at the clinical site on Day 1 and Day 15 (± 3 days) of the first 2 cycles, then on Day 1 (± 3 days) of every subsequent cycle (starting cycle 3), where safety assessments, including laboratory assessments, vital signs, and physical examinations will be performed.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 36 months for reporting.

Who is running the study

Principal Investigator
R. D. C.
Prof. Richard D. Carvajal, Associate Professor of Medicine at the Columbia University Medical Center
Columbia University

Closest Location

Columbia University Irving Medical Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Squamous Cell 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:
Histopathologically confirmed diagnosis of metastatic advanced cutaneous squamous cell carcinoma.
History of solid-organ transplant requiring immunosuppression
Progression of disease with estimated glomerular filtration rate (EGFR)-directed therapy
Age ≥ 18 yrs
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Karnofsky Performance Status Scale (KPS) ≥60%, Eastern Cooperative Oncology Group (ECOG) ≤2
No prior Janus kinase (JAK) Inhibitor therapy
Adequate organ function
All clinically significant toxicities from prior systemic therapy must be ≤ Grade 1 (with the exception of alopecia, and peripheral neuropathy, which may be ≤ grade 2).
Subjects must agree to undergo tumor biopsies until biopsies have been obtained from 10 subjects (i.e., biopsies are required in at least the first 10 enrolled subjects, or until a goal of 10 study biopsies are obtained). Subjects in whom a biopsy is technically not feasible or in whom would result in unacceptable risk in the opinion of the investigator, may be exempted from the biopsy requirement with discussion with the principal investigator.

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 are the signs of carcinoma, squamous cell?

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The tumour spreads outside the perineoscrotal area and presents as a single primary tumour in perineoscrotal or inguinal/hypogastric areas. This leads to inguinal or scrotal swelling and enlargement of the inguinal canal, which may be felt during the physical examination. The tumour may bleed and/or be soft at palpation, so careful, thorough palpation of the scrotum is vital.

Unverified Answer

What causes carcinoma, squamous cell?

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Most cancers start as carcinoma, squamous cell, and therefore the origin of these cancers may be in the nose or paranasal sinuses. Smoking is the most important modifiable factor.

Unverified Answer

Can carcinoma, squamous cell be cured?

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There were 5 deaths among the 100 patients in the study group, 1 death in the control group, and 5 patients still alive. There were many deaths in the study group.

Unverified Answer

What are common treatments for carcinoma, squamous cell?

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There are several treatment options for cancer. Overall and in particular, the most common treatments include radiation ond chemotherapy, surgery, and targeted therapy. These therapies are often necessary as there is often minimal local invasion as well when compared to squamous cell carcinoma. In this case, if there was any local tissue involvement, then the person would be evaluated for NAC as well. However, in the presence of local invasion, a radical resection of the cavity may be indicated in order to remove local tissue, in addition to surgical resection of any metastases. In such cases where local invasion is found, the person would then be treated for the same reasons as squamous cell carcinoma when it is metastatic.

Unverified Answer

How many people get carcinoma, squamous cell a year in the United States?

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Around 2 million people get squamous cell carcinoma of the bladder a year in the United States. Half of these cases could be avoided if those diagnosed with squamous cell carcinoma were screened for bladder cancer.

Unverified Answer

What is carcinoma, squamous cell?

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Carcinoma, squamous cell, is a malignancy of squamous epithelium. Squamous cell carcinoma of the anus (or anal cancer) is the second most common cancer after lung cancer in men. Most anal cancers occur in individuals who have previously had cancer in the rectum only. Many of these individuals had not received effective preventive care in the form of routine screening, and it is therefore recommended that such routine screening be improved in the United Kingdom and elsewhere. Squamous cell carcinoma of the penis is uncommon in young men who have never been circumcised. It occurs more commonly with HPV infection. A number of strategies against HPV infection are available.

Unverified Answer

Is ruxolitinib typically used in combination with any other treatments?

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There was a very high degree of synergy between ruxolitinib in combination treatments; all mCRC therapies with ruxolitinib were more efficacious in vivo than when dosed by itself (i.e., single-agent therapy). Further preclinical studies appear warranted to characterize how ruxolitinib and other JAK inhibitors can be added to these existing therapies.

Unverified Answer

Have there been any new discoveries for treating carcinoma, squamous cell?

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The recent development of targeted therapies have made the treatment of carcinomas in situ (CIS), and squamous cell carcinoma (SCC) much more effective, enabling more people to live longer. SCCs are the most common form of skin cancer. The development of SCCs may be limited by the discovery that the tumor suppression protein p53 mediates SCC in situ responses to DNA-damaging agents.

Unverified Answer

What are the chances of developing carcinoma, squamous cell?

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Carcinoma in situ, in situ microinvasion, and microinvasive carcinoma can all be diagnosed with similar detection rates (70%-80%). Thus, the chances of developing microinvasion or micrometastases (in situ, microinvasive, and invasive lesions) are extremely low. Carcinoma, in situ, and micrometastas have a greater chance of becoming carcinoma infiltrates. The clinical presentation of these cancers, therefore, will be different. However, the clinical presentation of these various tumours is not very important for the diagnosis and differential diagnosis of other conditions. In order to decide how best to treat a particular tumour, it is most important to make a correct diagnosis.

Unverified Answer

How does ruxolitinib work?

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Results from a recent clinical trial suggest that the mechanism by which Rux inhibits the growth of lung cancer cells is based on the inhibition of multiple signaling proteins. This is in contrast to the mechanism of action of alkylating agents, which target single proteins as their molecular targets. This knowledge is applicable to other anticancer drugs that can either be used alone or in combination with Rux.

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Have there been other clinical trials involving ruxolitinib?

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A phase 3 trial assessing ruxolitinib plus docetaxel chemotherapy demonstrated a very promising outcome; however, only half of the patients enrolled (95 patients) were allocated to the clinical trial. The full intent-to-treat analysis of the trial was not disclosed to the reader, leaving uncertainty as to what the study actually found. The U.S. Food and Drug Administration also did not disclose data from a phase 3 trial of the drug in combination with a chemotherapy. Another phase 2 trial investigated ruxolitinib therapy, and it found a similar outcome as the previous trial. Some of the results were also published in an editorial accompanying the article.

Unverified Answer

What are the common side effects of ruxolitinib?

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The most frequent GI and GI/metabolic side effects were nausea or vomiting (31%) and diarrhea (27%), respectively. Other side effects were fatigue (13%), dyspepsia (13%), and abdominal pain (10%); 6.9% of patients discontinued treatment due to these concerns. As of August 2015, ruxolitinib is being monitored in a randomized controlled trial investigating the role of ruxolitinib in treating inflammatory bowel disease (IBD) for which rhodium red has been approved as the radioactive tracer.

Unverified Answer
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