Mercaptopurine for the Treatment of Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC), Uterine/Cutaneous Leiomyomas, and Kidney Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07716735
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Kidney Carcinoma
  • Advanced Renal Cell Carcinoma
  • Hereditary Leiomyomatosis and Renal Cell Carcinoma
  • Metastatic Kidney Carcinoma
  • Metastatic Renal Cell Carcinoma
  • Skin Leiomyoma
  • Stage III Renal Cell Cancer AJCC v8
  • Stage IV Renal Cell Cancer AJCC v8
  • Uterine Corpus Leiomyoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Mercaptopurine — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Skin Biopsy — PROCEDURE
    Undergo skin biopsy

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Dec 1, 2026
Status verified
Jul 2026
Primary completion
Dec 1, 2034
Completion
Dec 1, 2035

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (6-MP)
    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).

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: Up to cycle 2 (Cycles = 28 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Brian Shuch (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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