Mocetinostat With Vinorelbine in Children, Adolescents & Young Adults With Refractory and/or Recurrent Rhabdomyosarcoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT04299113
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Rhabdomyosarcoma

Eligibility Criteria

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

Interventions

  • Vinorelbine — DRUG
    Given IV
  • Mocetinostat — DRUG
    Given PO

Study Details

This phase I trial studies the side effects and best dose of mocetinostat when given together with vinorelbine to see how well it works in treating children, adolescents, and young adults with rhabdomyosarcoma that has spread to nearby tissues or lymph nodes and cannot be removed by surgery (locally advanced unresectable) or has spread to other places in the body (metastatic), and does not respond to treatment (refractory) or has come back (relapsed). Mocetinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mocetinostat and vinorelbine may work better in treating children, adolescents, and young adults with rhabdomyosarcoma compared to vinorelbine alone.

Key Dates

Start date
May 14, 2020
Status verified
Jun 2025
Primary completion
May 22, 2026
Completion
May 22, 2027

Study Design

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

Arms

  • Experimental: Treatment (vinorelbine, mocetinostat)
    Participants receive mocetinostat in combination with vinorelbine

Primary Outcome Measure

To describe any dose-limiting toxicity (DLT) [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rebecca PhelanLos AngelesCalifornia90095-

Find similar trials in Los Angeles, CA

By research site
Rebecca Phelan· Los Angeles, CA

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