Mercaptopurine for Hereditary Leiomyomatosis and Renal Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I/II trial studies the side effects and best dose of mercaptopurine, and to see how well it works in treating patients with hereditary leiomyomatosis and renal cell carcinoma (HLRCC). HLRCC is a rare inherited disorder that increases the risk of developing benign (not cancer) tumors of the skin and the uterus (leiomyomas) and malignant (cancer) tumors of the uterus (leiomyosarcoma) and the kidney. Mercaptopurine is in a class of medications called purine antagonists. It works by stopping the growth of cancer cells.
Who Is on the Research Team?
Brian Shuch
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults (18+) with hereditary leiomyomatosis and renal cell carcinoma (HLRCC), kidney cancer, or multiple skin or uterine tumors. Participants need good organ function, specific genetic markers, and must not be pregnant. Certain recent treatments or serious health conditions may exclude people.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 6-MP orally once daily on days 1-28 of each cycle. Cycles repeat every 28 days for up to 26 cycles/2 years for kidney cohort or up to 13 cycles/1 year for skin or uterine cohorts.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up within 45 days and then every 12 months for 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Mercaptopurine
Trial Overview
The study tests different doses of mercaptopurine to find the safest and most effective amount for treating HLRCC-related cancers and tumors. It also uses scans, biopsies, and questionnaires to monitor effects. This is a phase I/II trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients receive 6-MP PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for up to 26 cycles/2 years (for kidney cohort) or up to 13 cycles/1 year (for skin or uterine cohorts) in the absence of disease progression or unacceptable toxicity. Patients may also undergo CT or MRI throughout the study (kidney and uterine cohorts only), tumor biopsy on study (kidney cohort only), skin biopsy on study (skin cohort only), and blood sample collection throughout the study (all cohorts).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
The V Foundation
Collaborator
Phase One Foundation
Collaborator
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