Ixabepilone in Treating Young Patients With Refractory Solid Tumors

NCT00331643 | Completed Phase 2

• 7 other identifiers: NCI-2012-01826COG-ADVL0524CDR0000472912NCI-P6451NCI-06-C-0146ADVL0524U10CA098543
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well ixabepilone works in treating young patients with refractory solid tumors. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

Adult Rhabdomyosarcoma; Adult Synovial Sarcoma; Alveolar Childhood Rhabdomyosarcoma; Childhood Synovial Sarcoma; Embryonal Childhood Rhabdomyosarcoma; Previously Treated Childhood Rhabdomyosarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor; Recurrent Neuroblastoma; Recurrent Osteosarcoma; Recurrent Wilms Tumor and Other Childhood Kidney Tumors

Outcome Measures

Primary Outcomes (4)

• Time to progression

  Estimated using the product-limit method of Kaplan and Meier.

  From enrollment until disease progression, death because of treatment complications, resection of measurable tumor or last patient follow-up whichever is first, assessed up to 5 years

• Progression-free survival (PFS)

  The probability of PFS at 6 months will be summarized.

  At 6 months

• Response rate (complete response [CR] and partial response [PR]) according to Response Evaluation Criteria in Solid Tumor (RECIST) and World Health Organization (WHO) criteria

  Response rates will be calculated as the percent of patients whose best response is a CR or PR, and the fraction of responses obtained will have a 95% confidence interval, which takes into consideration the two-stage nature of the design.

  Up to 5 years

• Toxicity as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

  Toxicity information recorded will include the type, severity, time of onset, time of resolution, and the probable association with the study regimen. Tables will be constructed to summarize the observed incidence by severity and type of toxicity.

  Up to 5 years

Study Arms (1)

Treatment (ixabepilone)

EXPERIMENTAL

Patients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.

Drug: ixabepilone

Interventions

ixabepilone DRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra

Treatment (ixabepilone)

Eligibility Criteria

• Age: 1 Year - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Histologically confirmed diagnosis (at original diagnosis or recurrence) of 1 of the following:
• Embryonal or alveolar rhabdomyosarcoma
• Osteosarcoma\*
• Ewing's sarcoma /peripheral neuroectodermal tumor\*
• Synovial sarcoma or malignant peripheral nerve sheath tumor\*
• Wilms' tumor\*
• Age ≤ 21 years at original diagnosis
• Neuroblastoma
• Age ≤ 21 years at original diagnosis
• Clinically or radiographically measurable or evaluable (by iodine I 123 metaiodobenzoguanine sulfate \[\^123I-MIBG\] or bone scan \[evaluable tumors must be positive at ≥ 1 site\])
• If lesion was previously irradiated, a biopsy must be performed ≥ 6 weeks after completion of radiotherapy and viable neuroblastoma must be demonstrated
• No elevated urinary catecholamines and/or bone marrow evidence of tumor with measurable disease clinically or by imaging modalities (CT scan, MRI, \^123I-MIBG, or bone scan)
• Refractory or recurrent disease with no known curative treatment options
• ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100% (patients \> 16 years of age) OR Lansky PS 50-100% (patients ≤ 16 years)
• Life expectancy ≥ 8 weeks

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

Rhabdomyosarcoma; Sarcoma, Synovial; Sarcoma; Neuroectodermal Tumors, Primitive, Peripheral; Neuroblastoma; Osteosarcoma; Wilms Tumor

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Bone Tissue; Neoplasms, Complex and Mixed; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplastic Syndromes, Hereditary; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Brigitte Widemann

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2006
• First Posted: May 31, 2006
• Study Start: April 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: June 1, 2009
• Last Updated: November 14, 2014

Record last verified: 2014-01

Locations

US (1)