Protocol Number: 06-C-0146

Title:

Phase II Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Children and Young Adults with Refractory Solid Tumors

Number:

06-C-0146

Summary:

Background:

-Ixabepilone is a member of a new class of anticancer drugs called epothilones, which interfere with the ability of cancer cells to divide. Ixabepilone kills cancer cells in the test tube and in animals.

-Epothilones are similar to a class of drugs called taxanes, which include Taxol® (Registered Trademark) (paclitaxel) and Taxotere® (Registered Trademark) (docetaxel). Epothilones can kill cancer cells that are resistant to Taxol® (Registered Trademark) in the laboratory.

-Ixabepilone has been tested in a small number of adults and children with cancers resistant to standard treatment.

Objectives:

-To measure the response of solid tumors to treatment with ixabepilone.

-To determine for how long ixabepilone can stop tumors from growing.

-To evaluate a new method of measuring tumors in the chest with a method that measures tumor volume.

-To further define the side effects of ixabepilone.

Eligibility:

-Patients with osteosarcoma, Ewing's sarcoma/peripheral neuroectodermal tumor, rhabdomyosarcoma, synovial sarcoma, malignant peripheral nerve sheath tumor, neuroblastoma, or Wilms tumor.

-Patients must be 12 months or older when entering the study.

-Patients with sarcoma must have been no more than 35 years old at the time of diagnosis.

-Patients with Wilms tumor or neuroblastoma must have been no more than 21 years old at the time of diagnosis.

Design:

-Up to 20 patients with each type of tumor may be enrolled.

-Patients are given ixabepilone as a 1-hour infusion through a vein on days 1-5 of every 21-day cycle.

-Patients have a physical exam and urine test before each cycle, blood tests weekly, pregnancy test (for women who can bear children) every other cycle, and tests to evaluate the tumor (radiological, imaging, or others, depending on the tumor type) after the first cycle and then after every other cycle.

-Patients may continue treatment as long as their tumor responds to therapy and the side effects are not unacceptable.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Taxane Analog

Volumetric Tumor Analysis

Response Rate

Time to Progression

Response Evaluation

Recruitment Keyword(s):

Solid Tumor

Rhabdomyosarcoma

Osteosarcoma

Ewing Sarcoma

Wilms Tumor

Neuroblastoma

Malignant Peripheral Nerve Sheath

Tumor

MPNST

Condition(s):

Neoplasms

Investigational Drug(s):

Ixabepilone

Investigational Device(s):

None

Interventions:

Drug: Ixabepilone

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Jordan A, Hadfield JA, Lawrence NJ, McGown AT. Tubulin as a target for anticancer drugs: agents which interact with the mitotic spindle. Med Res Rev. 1998 Jul;18(4):259-96. Review.

Wilson L, Jordan MA. Microtubule dynamics: taking aim at a moving target. Chem Biol. 1995 Sep;2(9):569-73. Review.

Huizing MT, Misser VH, Pieters RC, ten Bokkel Huinink WW, Veenhof CH, Vermorken JB, Pinedo HM, Beijnen JH. Taxanes: a new class of antitumor agents. Cancer Invest. 1995;13(4):381-404. Review.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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