Melphalan for Eye Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how the liver's immune system responds to the chemotherapy drug melphalan in patients with eye cancer (uveal melanoma) that has spread to the liver. Melphalan is delivered directly to the liver using Percutaneous Hepatic Perfusion (PHP), which targets the liver more effectively. The trial seeks participants diagnosed with uveal melanoma that has metastasized to the liver, who can undergo PHP, and have a liver tumor suitable for biopsy.
As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could enhance future treatments.
Do I need to stop my current medications to join the trial?
The trial requires that you stop taking certain medications, like high-dose systemic corticosteroids and some immunosuppressive drugs, at least two weeks before starting. If you're on anticoagulant or anti-platelet medications, they must be paused before a biopsy. Check with the trial team for specifics on your medications.
What prior data suggests that this method is safe for treating liver metastases from eye cancer?
A previous study found that delivering melphalan through Percutaneous Hepatic Perfusion (PHP) was generally safe and well-tolerated by patients. The study also showed that using a GEN 2 filter in this process reduced blood-related side effects.
Another study demonstrated that PHP with melphalan led to better outcomes for patients with liver tumors from eye cancer compared to other treatments, indicating the treatment's effectiveness and strong safety record.
The FDA has approved melphalan with PHP for treating metastatic uveal melanoma, confirming the treatment's safety and effectiveness for patients with this condition.12345Why are researchers excited about this trial?
Melphalan is unique because it is delivered through a specialized method called Percutaneous Hepatic Perfusion, which directly targets the liver's blood supply. This approach is particularly promising for eye cancer patients with liver metastases, as it allows high concentrations of melphalan to reach the cancer cells while potentially reducing systemic side effects. Unlike traditional chemotherapy, which circulates throughout the entire body, this targeted delivery system focuses the treatment where it's needed most, offering a more precise and potentially effective option. Researchers are excited about this technique because it could improve outcomes by maximizing the drug's impact on tumors while minimizing harm to healthy tissues.
What evidence suggests that melphalan through Percutaneous Hepatic Perfusion is effective for treating liver metastases from uveal melanoma?
Research has shown that using melphalan through Percutaneous Hepatic Perfusion (PHP) to treat liver cancer spread from eye melanoma is promising. In this trial, participants will receive melphalan through PHP. One study found that patients lived for a median of 20.5 months, with some experiencing benefits for 14 months. Another report demonstrated much better results compared to other treatments. Additionally, the overall response rate was significantly higher at 40%, compared to just 4.5% in a control group. These findings suggest that delivering melphalan directly to the liver can effectively manage this type of cancer spread.56789
Who Is on the Research Team?
Eric Wehrenberg-Klee, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 with uveal melanoma that has spread to the liver. They must have a life expectancy of more than 12 weeks, stable liver function tests, and be able to undergo percutaneous hepatic perfusion (PHP) with melphalan. Participants need measurable metastatic disease suitable for biopsy and an ECOG Performance Status of 0 or 1.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Biopsies and blood samples are collected to establish baseline measurements
Treatment
Participants receive a single dose of Melphalan via Percutaneous Hepatic Perfusion (PHP)
Follow-up
Participants return for a follow-up biopsy and peripheral blood draw to evaluate immune response
What Are the Treatments Tested in This Trial?
Interventions
- Melphalan
Trial Overview
The study is examining how the liver's immune system responds when treated with the chemotherapy drug melphalan administered through Percutaneous Hepatic Perfusion in patients whose eye cancer has spread to their liver.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Single arm
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Citations
Percutaneous hepatic perfusion with melphalan in uveal ...
After median follow‐up of 367 days, median overall progression free (PFS) and hepatic progression free survival (hPFS) was 8.1 and 9.1 months, respectively and ...
First Liver-Directed Therapy for Metastatic Uveal ...
The median duration of response was 14 months in the liver-directed melphalan group, with a median overall survival of 20.5 months compared to ...
Isolated Hepatic Perfusion With Melphalan for Patients ...
In an intention-to-treat analysis, the overall response rates (ORRs) were 40% versus 4.5% in the IHP and control groups, respectively (P < .0001) ...
Moffitt-Led International Study Finds New Drug Delivery ...
Patients treated with the melphalan hepatic delivery system experienced significantly improved outcomes than those receiving alternative care.
Survival Outcome After Percutaneous Hepatic Perfusion ...
After a median follow-up from the date of first M-PHP treatment of 25.8 months, the estimated median OS for the entire cohort was 29.1 months (95% CI: 18.4–38.9 ...
Safety of Percutaneous Hepatic Perfusion with Melphalan ...
Conclusions: M-PHP using the GEN 2 filter has an acceptable safety and toxicity profile, and seems to reduce hematologic toxicity when compared ...
Study Details | NCT02678572 | Percutaneous Hepatic ...
This study will evaluate patients who have melanoma that has spread from the eye to the liver: Patients in the study will be treated with Melphalan/HDS up ...
Percutaneous hepatic perfusion (PHP) with melphalan for ...
PHP demonstrates a statistically superior ORR and significantly prolonged PFS in comparison with BAC in the treatment of hepatic metastases from ocular ...
Percutaneous hepatic perfusion with melphalan in uveal ...
Melphalan percutaneous hepatic perfusion (M-PHP) allows selective intrahepatic delivery of high dose cytotoxic chemotherapy. Methods: Retrospective analysis of ...
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