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Melanoma (Skin)Early Phase 1NCT00962845

Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery

A Early Phase 1 study testing hydroxychloroquine in people with Melanoma (Skin), run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients with melanoma receiving hydroxychloroquine may help doctors understand the effect of hydroxychloroquine on biomarkers. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Melanoma (Skin)
What is being tested?
hydroxychloroquine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
Sep 2010to 30 May 2013
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 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed melanoma
  • Stage III or IV disease
  • Has ≥ 2 resectable tumors OR tumor large enough to undergo pre-treatment core needle biopsy
  • Must be a candidate for curative or palliative surgical resection of disease
  • Brain metastases allowed provided they were previously treated and have been stable for > 2 weeks

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Absolute granulocyte count > 1,500/mm³
  • Platelet count > 100,000/mm³
  • SGOT and SGPT < 2.5 times upper limit of normal (ULN)
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of any social or medical condition that, in the opinion of the investigator, may interfere with the patient's ability to comply with the study or pose additional or unacceptable risk to the patient
  • No concurrent serious systemic disorder that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
  • No active clinically significant infection requiring antibiotics
  • No hypertension that cannot be controlled by medication (i.e., diastolic blood pressure > 100 mm Hg despite optimal medical therapy)
  • No pre-existing thyroid abnormality with thyroid-stimulating hormone that cannot be maintained in the normal range with medication
  • No known HIV positivity
  • No psoriasis or porphyria
  • No known hypersensitivity to 4-aminoquinoline compounds
  • No retinal or visual field changes from prior 4-aminoquinoline compound use
  • No known G-6P deficiency
  • No known gastrointestinal pathology that would interfere with drug bioavailability
  • No known prior hypersensitivity to hydroxychloroquine or any of its components
  • No clinically significant bleeding or clotting disorder that would preclude curative or palliative surgery

PRIOR CONCURRENT THERAPY:

  • Recovered from prior therapy
  • More than 2 weeks since prior cytotoxic or biologic agents (6 weeks for mitomycin or nitrosoureas)
  • At least 2 weeks since prior surgery, radiotherapy, hormonal therapy, or other drug therapy for melanoma
  • No concurrent treatment for rheumatoid arthritis or systemic lupus erythematosus
  • No concurrent disease-modifying anti-rheumatic drugs
  • No concurrent hydroxychloroquine for treatment or prophylaxis of malaria
  • No concurrent aurothioglucose or antimalarial agents
  • No other concurrent chemotherapy, immunotherapy, hormonal therapy, radiotherapy, or surgery for cancer
  • No other concurrent investigational agents

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: A Phase 0 Trial of Hydroxychloroquine, an Inhibitor of Autophagy, in Patients With Stage III or IV Resectable Melanoma

RATIONALE: Studying samples of blood, tumor tissue, and skin in the laboratory from patients with melanoma receiving hydroxychloroquine may help doctors understand the effect of hydroxychloroquine on biomarkers.

PURPOSE: This early phase I trial is studying hydroxychloroquine in patients with stage III or stage IV melanoma that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • To characterize the effects of hydroxychloroquine (HCQ) on the modulation of markers of autophagy, as measured by p62, Beclin1, LC3, and GRp170 expression, in pre- and post-treatment tumor biopsy samples, skin samples, and peripheral blood mononuclear cell samples from patients with stage III or IV melanoma undergoing palliative or curative surgery.

Secondary

  • To determine whether the steady-state plasma concentration of HCQ correlates with observed trends in induced markers of autophagy.
  • To determine the potential mechanisms of antitumor effect of HCQ, as measured by a reduction in tumor cell proliferation (Ki-67 and mitotic rate) or an increase in apoptosis (activated caspase-3 and TUNEL assays) in melanoma specimens.

OUTLINE: Patients receive oral hydroxychloroquine twice daily for 14 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Blood, tumor tissue, and skin samples are collected for pharmacokinetic and correlative laboratory studies. Expression of p62, Beclin1, LC3, and GRp170 (autophagy markers) is analyzed.

Conditions
Melanoma (Skin)
Being tested
hydroxychloroquine
Keywords
stage III melanoma, stage IV melanoma
Medical subject headings
Melanoma

What participants receive

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

  • hydroxychloroquineDrug

    200 mg twice daily in the first ten patients. If the first ten patients tolerate this dosage schedule (200 mg bid) without significant side effects (Grade 3 or greater gastrointestinal upset, skin toxicity, myopathy or any visual disturbances whatsoever), the second ten patients will be enrolled at a dose of 400 mg bid

Study groups in NCT00962845
Study groupRoleWhat they receive
HydroxychloroquineExperimentalPatients must have tumor accessible for pre-treatment biopsy (see 5.1.2). Patients will be enrolled on the trial, undergo biopsy of their tumors if no banked tumor is available, and then begin an oral dose of HCQ at the dose of 200 mg twice daily. At the end of two weeks the patients will undergo resection of their tumors. HCQ will be given to the patients up to the day of the operation but not resumed postoperatively.
Receives: Drug: hydroxychloroquine

What is being measured

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

  1. Modulation of markers of autophagy by hydroxychloroquine (HCQ), as measured by p62, Beclin1, LC3, and GRp170 expression

    Measured: 1 year

Secondary outcomes (2)
  1. Correlation of steady-state plasma concentration of HCQ with observed trends in induced markers of autophagy

    Measured: 1 year

  2. Potential mechanisms of antitumor effect of HCQ, as measured by a reduction in tumor cell proliferation or an increase in apoptosis

    Measured: 1 year

Timeline

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

  1. First posted20 Aug 2009 (estimated)
  2. Study startSep 2010
  3. Primary completion30 May 2013
  4. Study completion30 May 2013

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00962845
Sponsor's protocol ID
0220090117
Other IDs
P30CA072720, CDR0000648156, NCI-2011-03324, 090901
Status last verified
Sep 2022
First submitted
19 Aug 2009
Last updated
7 Sep 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing hydroxychloroquine in people with Melanoma (Skin), run by Rutgers, The State University of New Jersey at 1 site in United States.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 7 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Modulation of markers of autophagy by hydroxychloroquine (HCQ), as measured by p62, Beclin1, LC3, and GRp170 expression (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 7 Sep 2022.

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