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Dabrafenib + Trametinib +/- Hydroxychloroquine for Melanoma
Study Summary
This trial is testing adding hydroxychloroquine to the standard treatment of dabrafenib and trametinib to see if it is more effective in treating patients with stage IIIC or IV BRAF V600E/K melanoma.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My melanoma is at an advanced stage and cannot be surgically removed.I have been treated with immune therapy for my cancer.I am not currently taking any medications that are not allowed.I do not have any serious infections, illnesses, or psychiatric conditions that would make this treatment unsafe for me.I do not have porphyria or psoriasis, or if I do, it is well-controlled and monitored by a specialist.I do not have serious heart rhythm problems, or if I have atrial fibrillation, it has been controlled for over 30 days.I have another cancer type, but it won't affect this trial's treatment.My tumor has the BRAF V600E or V600K mutation.My cancer can be measured and was checked within the last 3 weeks.I have never had interstitial lung disease or chronic pneumonitis.Your heart takes longer than it should to recover after beating.I've had BRAF and MEK inhibitors as part of my past treatment, stopped over 6 months ago, and didn't quit due to side effects.You have a heart valve problem that is moderate or severe, unless a heart doctor says it's not a big concern. If it's mild, you can still participate.I stopped my immunotherapy or chemotherapy more than 4 weeks ago.I haven't taken certain seizure medications in the last 4 weeks.I have treated brain metastases, no recent gamma knife therapy, and no unstable spinal issues.I am not on any current cancer treatments, except for pain relief or specific small brain metastases treatments.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.My hepatitis B virus load is undetectable with treatment.I had hepatitis C but am cured, or I'm being treated with no detectable virus.Your recent blood test showed that you have enough infection-fighting white blood cells.I can understand and am willing to sign the consent form, or I have someone who can do it for me.I am fully active or can carry out light work.Your bilirubin levels must be within the normal range at the time of the study.Your kidney function, as measured by creatinine levels, must be within a certain range.I have brain metastases but don't need immediate treatment for them.I have lung changes on scans that don't cause symptoms or need treatment.I do not have a history of heart problems.My heart's pumping ability is below the normal range.My heart function is classified as class 2B or better according to NYHA.I am using or willing to use effective birth control or abstain from sex during the study and for 4 months after.I haven't had a heart attack, unstable angina, or any heart procedures in the last 6 months.I stopped taking any targeted cancer pills at least 2 weeks ago.I am not currently having a partial response to immunotherapy.I can take pills and don't have major stomach or bowel issues affecting drug absorption.I have had chemotherapy or radiation therapy before.The levels of certain liver enzymes in your blood should not be more than three times the normal limit.Your platelet count is at least 100,000 per microliter within the last 14 days before joining the study.I have never had a blockage in the blood vessels of my eye.
- Group 1: Arm B (dabrafenib, trametinib, placebo)
- Group 2: Arm A (dabrafenib, trametinib, hydroxychloroquine)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research endeavor currently open to enrollees?
"At the present time, this trial is not enrolling new participants. Initially posted on October 23rd 2020, it was last revised on October 12th 2022. Melanoma patients have 816 available clinical trials and those interested in Hydroxychloroquine Sulfate can select from 155 active studies."
What potential risks come with utilizing Hydroxychloroquine Sulfate?
"Hydroxychloroquine Sulfate was deemed moderately safe with a score of 2, as it is currently in Phase 2 clinical trials where some data has been collected to support its safety profile but none for efficacy."
What is the geographical distribution of this trial?
"This research has launched out of Broadlawns Medical Center in Des Moines, Iowa, Greater Regional Medical Center in Creston, Florida and UM Sylvester Comprehensive Cancer Center at Aventura in Aventura Ohio. It is also taking place across an additional 100 sites."
Has Hydroxychloroquine Sulfate been examined in any prior investigations?
"The University of Nebraska Medical Center first began researching Hydroxychloroquine Sulfate in 2007, with 232 studies completed since then. Currently 155 trials are being conducted around the world; Des Moines, Iowa is a major hub for these investigations."
What is the cap on the enrollment of participants for this research?
"Currently, this clinical trial is not accepting new patients. Initially posted on October 23rd 2020, the study was most recently updated on October 12th 2022. For those looking for alternative trials, 816 studies are actively recruiting participants with melanoma while 155 are taking in volunteers to test Hydroxychloroquine Sulfate's efficacy."
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