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Adult RhabdomyosarcomaPhase 2NCT00331643

Ixabepilone in Treating Young Patients With Refractory Solid Tumors

A Phase 2 study testing ixabepilone in people with Adult Rhabdomyosarcoma and Adult Synovial Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 year to 35 years
What is being tested?
ixabepilone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Apr 2006to Jun 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 35 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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*
Show all 69Show fewer
  • 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
  • No evidence of active graft-versus-host disease
  • Absolute neutrophil count ≥ 1,500/mm³ (no growth factors)
  • Platelet count ≥ 75,000/mm³ (transfusion independent)
  • Not pregnant or nursing
  • Fertile patients must agree to use effective contraception
  • Negative pregnancy test
  • Hemoglobin ≥ 8 g/dL (may receive RBC transfusions)
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT ≤ 2.5 times ULN
  • No clinically significant unrelated systemic illness that would preclude study treatment, including any of the following:
  • Serious infections
  • Hepatic, renal, or other organ dysfunction
  • CNS toxicity ≤ grade 2
  • No pre-existing sensory or motor neuropathy ≥ grade 2
  • Seizure disorder allowed provided it is well controlled by anticonvulsants
  • No known prior severe hypersensitivity reaction to agents containing Cremophor EL®
  • Fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
  • More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks if prior nitrosourea)
  • At least 7 days since prior biologic agents
  • At least 2 weeks since prior local palliative (small-port) radiotherapy
  • At least 6 months since prior craniospinal radiotherapy OR radiotherapy to ≥ 50% of the pelvis
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • At least 4 months since prior allogeneic stem cell transplant (SCT)
  • At least 2 months since prior autologous SCT
  • No prior taxane (paclitaxel, docetaxel) therapy
  • More than 1 week since prior growth factor use (except epoetin alfa)
  • More than 1 week since prior and no concurrent strong inhibitors ofCYP3A4, including any of the following:
  • Clarithromycin
  • Troleandomycin
  • Erythromycin
  • Ketoconazole
  • Itraconazole
  • Fluconazole (doses > 3mg/kg/day)
  • Voriconazole
  • Nefazodone
  • Fluvoxamine
  • Verapamil
  • Diltiazem
  • Amiodarone
  • Grapefruit juice
  • More than 1 week since prior and no concurrent enzyme-inducing anticonvulsants, including any of the following:
  • Carbamazepine
  • Felbamate
  • Phenobarbital
  • Phenytoin
  • Primidone
  • Oxcarbazepine
  • No concurrent aprepitant
  • No concurrent Hypericum perforatum (St. John's wort)
  • No concurrent sargramostim (GM-CSF) or interleukin-11
  • No other concurrent chemotherapy or immunomodulating agents
  • No concurrent radiotherapy
  • Concurrent steroids allowed for pain or chemotherapy-associated nausea or vomiting

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Oncology Group

    Arcadia, California, 91006-3776

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the response rate to ixabepilone in various strata of recurrent solid malignant tumors of childhood and young adulthood, including all of the following: Embryonal or alveolar rhabdomyosarcoma, osteosarcoma, Ewing's sarcoma/peripheral neuroectodermal tumor, synovial sarcoma or malignant peripheral nerve sheath tumor, Wilms' tumor, and neuroblastoma.

II. Determine the time to progression for each tumor stratum. III. Prospectively evaluate the feasibility and utility of automated volumetric tumor measurement in patients with measurable pulmonary metastases, and descriptively compare volumetric measurements to 1-dimensional (RECIST criteria) and 2-dimensional (WHO criteria) measurements.

IV. Define and describe the toxicities of ixabepilone.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (Ewing's sarcoma/ peripheral neuroectodermal tumor vs osteosarcoma vs alveolar or embryonal rhabdomyosarcoma vs Wilms' tumor vs neuroblastoma vs synovial sarcoma/malignant peripheral nerve sheath tumor).

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.

After completion of study treatment, patients are followed up every year for 5 years.

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Being tested
ixabepilone
Medical subject headings
Rhabdomyosarcoma, Sarcoma, Synovial, Sarcoma, Neuroectodermal Tumors, Primitive, Peripheral, Neuroblastoma, Osteosarcoma, Wilms Tumor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ixabepiloneDrug

    Also called BMS-247550, epothilone B lactam, Ixempra

    Given IV

Study groups in NCT00331643
Study groupRoleWhat they receive
Treatment (ixabepilone)ExperimentalPatients receive ixabepilone IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
Receives: Drug: ixabepilone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to progression

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

    Measured: 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

  2. Progression-free survival (PFS)

    The probability of PFS at 6 months will be summarized.

    Measured: At 6 months

  3. 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.

    Measured: Up to 5 years

  4. 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.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionOct 2007
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00331643
Sponsor's protocol ID
NCI-2012-01826
Other IDs
NCI-2012-01826, COG-ADVL0524, CDR0000472912, NCI-P6451, NCI-06-C-0146, ADVL0524, ADVL0524, U10CA098543
Status last verified
Jan 2014
First submitted
30 May 2006
Last updated
14 Nov 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone in people with Adult Rhabdomyosarcoma and Adult Synovial Sarcoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 69 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to progression (time frame: 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00331643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2014.

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