Conditions: Chronic Myeloproliferative Disorders Secondary Myelofibrosis
Keywords: secondary myelofibrosis polycythemia vera essential thrombocythemia primary myelofibrosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 77
Healthy volunteers: no

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.

Arms:
arm 1: None

Interventions: intervention 1: CC-4047
Intervention descriptions: intervention 1: CC-4047: taken orally each day in a 28 day cycle.

Protocol document: