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Skin Basal Cell CarcinomaEarly Phase 1NCT02699723

Arsenic Trioxide and Itraconazole in Treating Patients With Advanced Basal Cell Cancer

A Early Phase 1 study testing Arsenic Trioxide, Itraconazole and Laboratory Biomarker Analysis in people with Skin Basal Cell Carcinoma, run by Jean Yuh Tang.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot clinical trial studies how well arsenic trioxide and itraconazole work in treating patients with basal cell cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Basal Cell Carcinoma
What is being tested?
Arsenic Trioxide, Itraconazole and Laboratory Biomarker Analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2020to Sep 2021
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Basal cell carcinoma (BCC)
  • Patients ineligible for curative locoregional treatment and have either progressed on, did not tolerate, unwilling to try or ineligible for investigational smoothened antagonist such as Erivedge or Odomzo
  • Life expectancy estimate > 3 months
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0 to 2
  • Absolute neutrophil count >= 1,500/mcL
  • Platelets >= 100,000/mcL
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  • Total bilirubin within normal institutional limits
  • Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =< 2.5 X institutional upper limit of normal
  • Creatinine =< 1.9 mg/dL
  • Corrected QT (QTC) by 12 lead electrocardiography (EKG) < 450 msecs
  • Serum potassium, magnesium and calcium levels which fall within normal limits or levels outside the normal range determined not to be clinically significant by the principal investigator (PI)
  • Serum prothrombin time, international normalized ratio (INR) and partial thromboplastin times which fall within normal limits or levels outside the normal range determined not to be clinically significant by the PI
  • Ability to understand and the willingness to sign a written informed consent document
  • Females and males of reproductive potential must use effective contraception during and after treatment for 6 months

Who cannot join

  • Concurrent use of other investigational agents
  • Cardiac arrhythmias
  • Receiving potassium wasting diuretics or amphotericin must be noted to have theoretically increased arrhythmia risks with arsenic trioxide (potassium wasting diuretics or amphotericin are not excluded)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, liver disease, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, recurrent seizure history or psychiatric illness/social situations that would limit compliance with treatment requirements
  • Currently taking systemic medications that would affect BCC tumors (oral retinoids) or metabolism of itraconazole (anti convulsants and corticosteroids); itraconazole should not be taken with cisapride (Propulsid), dofetilide (Tikosyn), oral midazolam (Versed), nisoldipine (Sular), pimozide (Orap), quinidine (Quinaglute), triazolam (Halcion), or levomethadyl (Orlaam), lovastatin (Mevacor), simvastatin (Zocor), or an ergot medication such as dihydroergotamine (Migranal), ergometrine or ergonovine (Ergotrate Maleate), ergotamine (Ergomar), or methylergometrine or methylergonovine (Methergine)
  • History or current evidence of malabsorption or liver disease that would impair the absorption of itraconazole
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  • History or current evidence of hyperthyroidism that would increase metabolism of itraconazole
  • Immunosuppressed patients (cancer, autoimmune disease) or patients taking immunosuppressive drugs
  • Pregnant or breastfeeding

About this study

Official title: Oral Arsenic Trioxide and Itraconazole for the Treatment of Patients With Advanced Basal Cell Carcinoma

This pilot clinical trial studies how well arsenic trioxide and itraconazole work in treating patients with basal cell cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Itraconazole may help treat fungal infections in patients with basal cell cancer. Giving arsenic trioxide with itraconazole may work better in treating basal cell cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the response of arsenic trioxide/itraconazole in patients with refractory basal cell carcinoma.

SECONDARY OBJECTIVES:

  1. To determine if this treatment is associated with a reduction in Gli messenger ribonucleic acid (mRNA) levels in tumor and/or normal skin biopsy samples, when compared to baseline levels.

OUTLINE:

Patients receive arsenic trioxide orally (PO) and itraconazole PO daily for 50 days, followed by maintenance therapy consisting of 2 weeks off treatment and then 2 weeks on treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Being tested
Arsenic Trioxide, Itraconazole, Laboratory Biomarker Analysis
Medical subject headings
Carcinoma, Basal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arsenic TrioxideDrug

    Also called Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid, Arsenous Acid Anhydride

    Given PO

  • ItraconazoleDrug

    Also called Lozanoc, Oriconazole, R 51,211, Sporanox

    Given PO

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT02699723
Study groupRoleWhat they receive
Treatment (arsenic trioxide, itraconazole)ExperimentalPatients receive arsenic trioxide PO and itraconazole PO daily for 50 days, followed by maintenance therapy consisting of 2 weeks off treatment and then 2 weeks on treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Arsenic Trioxide; Drug: Itraconazole; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Gli levels

    Nonparametric methods (Wilcoxon sign rank test) will be used given then the continuous outcome and small sample size.

    Measured: Baseline to up to 1 month

Secondary outcomes (1)

  1. Tumor response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria

    Proportion of subjects with complete response, partial response, stable disease, or disease progression by RECIST criteria.

    Measured: At 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2016 (estimated)
  2. Study startDec 2020 (estimated)
  3. Primary completionSep 2021 (estimated)
  4. Study completionSep 2021 (estimated)

Why it stopped: Logistics

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02699723
Sponsor's protocol ID
IRB-35488
Other IDs
NCI-2016-00180, SKIN0033
Status last verified
Oct 2020
First submitted
1 Mar 2016
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Arsenic Trioxide, Itraconazole and Laboratory Biomarker Analysis in people with Skin Basal Cell Carcinoma, run by Jean Yuh Tang.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Gli levels (time frame: Baseline to up to 1 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02699723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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