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Recurrent MelanomaPhase 2NCT00036764

BMS-247550 in Treating Patients With Stage IV Melanoma

A Phase 2 study testing ixabepilone, pharmacogenomic studies and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, 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

Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
ixabepilone, pharmacogenomic studies and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteUnited States
Study dates
Feb 2002to Aug 2004
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed stage IV melanoma
  • At least 1 measurable lesion
  • Greater than 20 mm by conventional techniques
  • Greater than 10 mm by spiral CT scan
  • Known brain metastases allowed if all of the following criteria are met:
  • Radiologically stable for at least 6 weeks after completion of whole brain radiotherapy
Show all 40Show fewer
  • Stable at time of study
  • No mass effect present radiologically
  • No concurrent steroids to control symptoms of brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • At least 3 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper limit of normal (ULN)
  • Creatinine no greater than 1.5 times ULN
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior severe allergic reactions (grade III or IV or grade II not responsive to steroids) to taxanes or medications containing Cremophor EL
  • No pre-existing grade 2 or greater peripheral neuropathy
  • No HIV-positive patients receiving combination antiretroviral therapy
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness that would preclude study
  • Prior vaccine therapy allowed
  • Prior immunotherapy (e.g., interleukin-2 or interferon) allowed
  • Stratum I:
  • No prior chemotherapy
  • Stratum II:
  • No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide)
  • See Disease Characteristics
  • See Disease Characteristics
  • Prior limb-perfusion therapy allowed (stratum II)
  • No other concurrent investigational or commercial agents or therapies intended to treat malignancy
  • No concurrent Hypericum perforatum

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • New York University Clinical Cancer Center

    New York, New York, 10016-4760

Other trials in United States

About this study

Official title: A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma

Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Read the detailed description

OBJECTIVES:

  1. Determine the efficacy of BMS-247550 in patients with stage IV melanoma. II. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to the number of prior chemotherapy regimens (0 vs 1-2, including dacarbazine or temozolomide).

Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Being tested
ixabepilone, pharmacogenomic studies, laboratory biomarker analysis
Medical subject headings
Melanoma

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

  • pharmacogenomic studiesOther

    Also called Pharmacogenomic Study

    Correlative studies

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00036764
Study groupRoleWhat they receive
TreatmentExperimentalPatients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: ixabepilone; Other: pharmacogenomic studies; Other: laboratory biomarker analysis

What is being measured

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

  1. Response rate

    The 95% confidence intervals will be provided.

    Measured: Up to 2 years

Secondary outcomes (2)

  1. Median time to progression

    Median time to progression will be described for each subgroup.

    Measured: Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years

  2. Incidence of related toxicities graded according to the revised NCI CTC version 2.0

    Related toxicities will be described.

    Measured: Up to 2 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2002
  3. Primary completionAug 2004

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
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00036764
Sponsor's protocol ID
NCI-2012-02464
Other IDs
NYU-0057, N01CM17103, CDR0000069320
Status last verified
Jan 2013
First submitted
13 May 2002
Last updated
25 Jan 2013
Results posted
No

Publications

  • Ott PA, Hamilton A, Jones A, Haas N, Shore T, Liddell S, Christos PJ, Doyle LA, Millward M, Muggia FM, Pavlick AC. A phase II trial of the epothilone B analog ixabepilone (BMS-247550) in patients with metastatic melanoma. PLoS One. 2010 Jan 20;5(1):e8714. doi: 10.1371/journal.pone.0008714.

    PubMed 20098694

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ixabepilone, pharmacogenomic studies and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, 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 40 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 25 Jan 2013. 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?

Response rate (time frame: Up to 2 years). 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 NCT00036764, which also lists 1 linked publication.

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 25 Jan 2013.

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