MelanomaPhase 1NCT01897116
A Phase I Trial of Vemurafenib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma
A Phase 1 study testing Hydroxychloroquine (HCQ) and Vemurafenib (VEM) in people with Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of BRAF V600E+ metastatic melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Hydroxychloroquine (HCQ) and Vemurafenib (VEM)
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 5 Oct 2016
- Phase
- 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
- Patients must be at least 18 years of age.
- Patients must have histologically confirmed diagnosis of Stege IV metastic melanoma positive for BRAF V600E mutation by either the COBAS test or other CLIA approved assay.
- Patients must have a ECOG performance status of 0 or 1.
- Patients must have the following hematologic, renal and liver function: absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, hemoglobin >9g/dL, creatinine ≤ 2 times the upper limits of normal (ULN), albumin > 2g/dL, total bilirubin ≤ 1.5 mg/dl, ALT and AST ≤ 3 times above the upper limits of the institutional norm.
- Patients must be able to provide written informed consent.
- Negative serum pregnancy test within 7 days prior to commencement of dosing in premenopausal women. Women of non-childbearing potential may be included without serum pregnancy test if they are either sugically sterile or have been postmenopausal for ≥ 1 year.
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- Fertile men and women must an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistenly and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the Investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence (e.g. calendar, ovulation, sympothermal, postovulation methods) with withdrawal are not acceptable methods of contraception.)
- Patients with treated brain metastases that have been stable for 1 month are eligible; patients must be off steroids for 1 week prior to starting study treatment.
- Any number and type of prior anticancer therapies except BRAF or MEK inhibitors.
- Patients must have discontinued active immunotherapy (IL-2, interferon, CTLA-4, etc.) or chemotherapy at least 4 weeks prior to entering the study and oral targeted therapy at least 2 weeks prior to entering the study and have recovered from adverse events due to those agents. Patients must not receive any other investigational anticancer therapy during the period on study or the four weeks prior to entry, with the exception of vaccines.
Who cannot join
- Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
- Patients who are pregnant and breast-feeding.
- Patients receiving concurrent therapy for their tumor (i.e.chemotherapeutics or investigational agents).
- Patients with leptomeningeal disease.
- Patients with a concurrent or prior malignancy within the last 2 years, unless they are patients with curatively treated carcinoma-in-situ, or basal cell carcinoma or squamous cell carcinoma of the skin. Patients with treated prostate cancer or breast cancer for which no concurrent therapy is indicated are eligible for this study. Patients who have been free of disease (any prior malignancy) for ≥ five years are eligible for this study.
- Due to risk of disease exacerbation patients with porphyria are not eligible.
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- Due to risk of disease exacerbation patients with psoriasis are ineligible unless the disease is well controlled and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
- Patients receiving cytochrome P450 enzyme-inducing anticonvulsant drugs (EIADs) (i.e. phenytoin, carbamazepine, Phenobarbital, primidone, or oxcarbazepine) are ineligible.
- Patients with previously documented macular degeneration or diabetic retinopathy are ineligible.
- Patients with prior exposure to BRAF or MEK inhibitors are not eligible.
- Because patients witn immune deficiency are at increased risk of lethal infections when treated with bone marrow-suppressive therapy, HIV-positive patients are excluded from the study. For patients receiving combination anti-retroviral therapy, the potential impact of pharmacokinetic interactions with HCQ and VEM is unknown. Appropriate studies may be undertaken in patients with HIV and those receiving combination anti-retrovital therapy in the future.
- History of congenital long QT syndrome or a corrected QTc interval ≥ 450 msec at baseline.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of BRAF V600E+ metastatic melanoma.
Read the detailed description
This study is testing vemurafenib and hydroxychloroquine (HCQ) in the treatment of metastatic BRAF V600E+ melanoma. Patients will be getting a known active treatment for their disease in combination with HCQ which may help overcome resistance so that responses to vemurafenib are more durable.
- Conditions
- Melanoma
- Being tested
- Hydroxychloroquine (HCQ), Vemurafenib (VEM)
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine (HCQ)Drug
Vemurafenib (VEM)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2013
- Primary completion12 Jul 2016
- Study completion5 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Amaravadi, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01897116
- Sponsor's protocol ID
- UPCC 06613
- Status last verified
- May 2020
- First submitted
- 26 Jun 2013
- Last updated
- 29 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Vemurafenib and Hydroxychloroquine in Patients With Advanced BRAF Mutant Melanoma
- ClinicalTrials.gov ID
- NCT01897116
- Acronym / sponsor ID
- UPCC 06613
- Conditions
- Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 12 Jul 2016 (actual)
- Study completion
- 5 Oct 2016 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I study combining vemurafenib and hydroxychloroquine in the treatment of BRAF V600E+ metastatic melanoma.
Detailed description
This study is testing vemurafenib and hydroxychloroquine (HCQ) in the treatment of metastatic BRAF V600E+ melanoma. Patients will be getting a known active treatment for their disease in combination with HCQ which may help overcome resistance so that responses to vemurafenib are more durable.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must be at least 18 years of age.
- Patients must have histologically confirmed diagnosis of Stege IV metastic melanoma positive for BRAF V600E mutation by either the COBAS test or other CLIA approved assay.
- Patients must have a ECOG performance status of 0 or 1.
- Patients must have the following hematologic, renal and liver function: absolute neutrophil count > 1500/mm3, platelets > 100,000/mm3, hemoglobin >9g/dL, creatinine ≤ 2 times the upper limits of normal (ULN), albumin > 2g/dL, total bilirubin ≤ 1.5 mg/dl, ALT and AST ≤ 3 times above the upper limits of the institutional norm.
- Patients must be able to provide written informed consent.
Key exclusion criteria (12 listed)
- Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
- Patients who are pregnant and breast-feeding.
- Patients receiving concurrent therapy for their tumor (i.e.chemotherapeutics or investigational agents).
- Patients with leptomeningeal disease.
- Patients with a concurrent or prior malignancy within the last 2 years, unless they are patients with curatively treated carcinoma-in-situ, or basal cell carcinoma or squamous cell carcinoma of the skin. Patients with treated prostate cancer or breast cancer for which no concurrent therapy is indicated are eligible for this study. Patients who have been free of disease (any prior malignancy) for ≥ five years are eligible for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine (HCQ) | Drug | – |
| Vemurafenib (VEM) | Drug | – |
Primary outcome
Number of Adverse Events
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Amaravadi, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxychloroquine (HCQ) and Vemurafenib (VEM) in people with Melanoma, run by Abramson Cancer Center at Penn Medicine 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?
The sponsor lists 10 inclusion and 12 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: finished, as of the sponsor's last update on 29 May 2020. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of Adverse Events (time frame: 8 weeks). 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 29 May 2020.