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BMS-247550 in Treating Patients With Stage IV Melanoma

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00036764
Enrollment
88
Registered
2003-01-27
Start date
2002-02-28
Completion date
Unknown
Last updated
2013-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent Melanoma, Stage IV Melanoma

Brief 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

Detailed description

OBJECTIVES: I. 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.

Interventions

DRUGixabepilone

Given IV

OTHERpharmacogenomic studies

Correlative studies

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Response rateUp to 2 yearsThe 95% confidence intervals will be provided.

Secondary

MeasureTime frameDescription
Median time to progressionTime from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 yearsMedian time to progression will be described for each subgroup.
Incidence of related toxicities graded according to the revised NCI CTC version 2.0Up to 2 yearsRelated toxicities will be described.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026