High Dose Melphalan for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat breast cancer that has spread to the liver, using a high dose of the chemotherapy drug Melphalan. Researchers aim to determine if this liver-focused treatment, followed by standard cancer care, is safe and effective compared to standard cancer care alone. Participants will receive either the Melphalan treatment combined with a standard cancer drug or just the standard drug. This trial may suit those with breast cancer primarily spread to the liver and who are suitable for single-agent chemotherapy like eribulin, vinorelbine, or capecitabine. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer care.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Past studies have shown both benefits and concerns when using melphalan to treat cancer. Research indicates that high doses of melphalan can be effective for certain cancer types. However, it can also cause side effects, particularly those related to blood and other health issues. One study found that high-dose melphalan had fewer blood-related and other side effects compared to some other treatments, but it can still be taxing on the body.
Melphalan is also a known carcinogen, meaning it could potentially cause cancer itself, and it has been linked to cases of acute leukemia. This is why doctors closely monitor its use. Reports have indicated a higher risk of death when used with some other drugs, but this occurred in different situations than in the current trial.
Prospective trial participants should discuss these potential risks and benefits with their healthcare provider to determine if melphalan is appropriate for them.12345Why are researchers excited about this trial's treatments?
Researchers are excited about high-dose Melphalan for breast cancer because it introduces a new delivery method by infusing the drug directly into the hepatic artery. This targeted approach aims to maximize the drug's impact on cancer cells in the liver, potentially leading to more effective treatment outcomes. Unlike standard chemotherapy options like eribulin, vinorelbine, or capecitabine, which are administered systemically, this method focuses on delivering concentrated doses precisely where they are needed most. By doing so, it could offer improved efficacy and reduced side effects compared to traditional systemic treatments.
What evidence suggests that this trial's treatments could be effective for breast cancer that has spread to the liver?
Research has shown that melphalan may help treat cancers, including breast cancer that has spread to the liver. In this trial, one group of participants will receive high-dose melphalan through hepatic artery infusion, followed by the physician's choice of standard-of-care treatments (eribulin, vinorelbine, or capecitabine). Studies have found that high doses of melphalan can cause more tumors to shrink or disappear completely. For breast cancer that has primarily spread to the liver, treatments like percutaneous hepatic perfusion with melphalan have demonstrated some positive results. Melphalan can combat various types of cancer, not just multiple myeloma, a bone marrow cancer. Its effects on breast cancer remain under investigation.14678
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Treatment
Participants undergo up to two cycles of liver-directed therapy with high dose chemotherapy procedures
Consolidation Treatment
Participants receive approved cancer treatment (eribulin, vinorelbine, or capecitabine) following liver-directed therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Capecitabine
- Eribulin
- Melphalan
- Vinorelbine
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Melphalan/HDS is given as an infusion of Melphalan into the hepatic artery under general anesthesia. This treatment is administered then followed by Physician's choice of SOC (eribulin, vinorelbine, or capecitabine) then repeated for a second cycle of Melphanlan/HDS followed by Physician's choice of SOC.
Physician's choice of SOC (eribulin, vinorelbine, or capecitabine)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Delcath Systems Inc.
Lead Sponsor
Citations
Randomized comparison of vinorelbine and melphalan in ...
034): 1-year survival rates were 35.7% with NVB and 21.7% with ALK and the median survival rate was 35 weeks and 31 weeks, respectively. In total, 46.5% of NVB ...
2.
clinical-lymphoma-myeloma-leukemia.com
clinical-lymphoma-myeloma-leukemia.com/article/S2152-2650(25)04302-2/fulltextReal-World Outcomes of High Dose Melphalan and ...
Survival, treatment response, complication rates, and long-term quality of life were comparable between age groups. Our real-world data confirm the safety and ...
3.
cancernetwork.com
cancernetwork.com/view/consider-high-dose-melphalan-standard-conditioning-multiple-myelomaConsider High-Dose Melphalan as Standard Conditioning ...
“We concluded there is no significant difference in outcome between these regimens, but the hematologic and extrahematologic toxicities are lower with high-dose ...
4.
oncologynurseadvisor.com
oncologynurseadvisor.com/news/multiple-myeloma-melphalan-achieves-survival-outcomes-relapse-rates/Low-Dose Melphalan Achieves Survival Outcomes ...
High-dose treatment was associated with a higher complete response rate (66.2%) and very good partial response rate (17.2%) but lower partial ...
Controlled trial of adjuvant chemotherapy with melphalan ...
The results of this trial suggest that there is no place for the use of melphalan as adjuvant therapy in the management of early breast cancer.
Melphalan - 15th Report on Carcinogens - NCBI Bookshelf
Melphalan is known to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in humans.
Delcath Systems Announces Presentation of New Data on ...
Delcath Systems Announces Presentation of New Data on Percutaneous Hepatic Perfusion with Melphalan in Liver-Dominant Metastatic Breast Cancer ...
Melphalan: Recent insights on synthetic, analytical and ...
Another study showed that some melphalan dipeptides also exhibited less toxicity and increased chemotherapeutic indices than melphalan [19].
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.