Clinical trial NCT00036764: BMS-247550 in Treating Patients With Stage IV Melanoma
Official title: A Phase II Study Of Epothilone B Analog BMS 247550 (NSC # 710428) In Stage IV Malignant Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Melanoma
Stage IV Melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate
timeFrame: Up to 2 years
Secondary outcomes:
measure: Median time to progression
timeFrame: Time from the first day of treatment with BMS 247550 until the first documentation of disease progression, assessed up to 2 years
measure: Incidence of related toxicities graded according to the revised NCI CTC version 2.0
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Clinical Cancer Center
state: New York
Study officials:
affiliation: New York University Clinical Cancer Center
name: Anna Pavlick
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.