Spots Global Cancer Trial Database for CC-4047 in Treating Patients With Myelofibrosis

Study Description

Brief Summary: RATIONALE: Biological therapies, such as CC-4047, may stimulate the immune system in different ways and stop cancer cells from growing. CC-4047 may also stop the growth of cancer cells by blocking blood flow to the cancer. PURPOSE: This trial is studying the side effects and best dose of CC-4047 and to see how well it works in treating patients with myelofibrosis.

Detailed Description: OBJECTIVES: Phase I: Primary * To determine the Maximum Tolerated Dose of CC-4047 in the treatment of Primary, Post Polycythemia Vera, or Post Essential Thrombocythemia Myelofibrosis (PMF, post-PV MF, or post-ET MF). Phase II: Primary * Best overall response as determined by International Working Group Criteria over the first 6 cycles (168 days) of study treatment. Secondary * Safety (type, frequency, severity \[National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0\] of adverse events (AEs), and relationship of AEs to CC-4047. * Duration of response. * Time to response. * Best overall response as determined by International Working Group Criteria over the first 12 cycles (336 days) of study treatment. OUTLINE: Patients receive oral CC-4047. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 28 days and then every 6 months for up to 3 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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