Clinical Trial: A Study of Lenalidomide for Adult Histiocyte Disorders

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase II Study of Lenalidomide for Adult Histiocyte Disorders

Brief Summary: This research study is studying a chemotherapy drug Lenalidomide as a possible treatment for one of three histiocyte disorders: Langerhans cell histiocytosis (LCH), Erdheim-Chester disease (ECD), or histiocytic sarcoma (HS).

Detailed Summary:

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved lenalidomide for your specific disease but it has been approved for other uses. Lenalidomide is a chemotherapy drug that belongs to a class of drugs called immunomodulatory drugs (IMiDs), which modify a participant's immune response in order to treat cancer. Lenalidomide alters the body's immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, it may reduce or prevent the growth of cancer cells. Lenalidomide has been shown to restore the immune cells' ability to attack and kill tumor cells Lenalidomide is approved by the FDA to treat certain cancers including multiple myeloma and myelodysplastic syndrome.


Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Response Rate [ Time Frame: 12 Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression Free Survival (PFS) [ Time Frame: 12 Months ]
  • Overall Survival [ Time Frame: 12 Months ]
  • Number of Participating with Grade 3-4 toxicity [ Time Frame: 12 Months ]
  • Quantitative serial measurements of urine cell free DNA for BRAF mutation as a biomarker of response [ Time Frame: 12 Months ]
  • Quantitative serial measurements of serum TNF-alpha levels as a biomarker of response [ Time Frame: 12 Months ]
  • Quantitative serial measurements of plasma cell free DNA for BRAF mutation as a biomarker of response [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: August 12, 2015
Date Started: August 2015
Date Completion: August 2022
Last Updated: September 7, 2016
Last Verified: September 2016