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| ID | Type | Description | Link |
|---|---|---|---|
| CAN-NCIC-IND169 | |||
| CDR0000391842 | Other Identifier | PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with metastatic or recurrent malignant melanoma.
OBJECTIVES:
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
All patients are followed at 4 weeks after completion of protocol therapy. Patients with ongoing complete response, partial response, or stable disease are followed every 3 months thereafter until relapse.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-14 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ispinesib | Drug | SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Response | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 2 years | |
| Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed) | 2 years | |
| Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs) |
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DISEASE CHARACTERISTICS:
Histologically confirmed malignant melanoma
Measurable disease
At least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Bone metastases are not considered measurable disease
Outside any previously irradiated area
No known CNS metastases
Archival paraffin tumor specimen available
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
More than 28 days since prior investigational agents
More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
At least 6 months since prior and no concurrent amiodarone
No concurrent antiretroviral therapy for HIV-positive patients
No other concurrent anticancer treatment
No other concurrent investigational therapies
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Lee, MD | BCCA - Fraser Valley Cancer Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| British Columbia Cancer Agency - Centre for the Southern Interior | Kelowna | British Columbia | V1Y 5L3 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17962907 | Result | Lee CW, Belanger K, Rao SC, Petrella TM, Tozer RG, Wood L, Savage KJ, Eisenhauer EA, Synold TW, Wainman N, Seymour L. A phase II study of ispinesib (SB-715992) in patients with metastatic or recurrent malignant melanoma: a National Cancer Institute of Canada Clinical Trials Group trial. Invest New Drugs. 2008 Jun;26(3):249-55. doi: 10.1007/s10637-007-9097-9. Epub 2007 Oct 26. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C508757 | ispinesib |
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| 2 years |
| Fraser Valley Cancer Centre at British Columbia Cancer Agency |
| Surrey |
| British Columbia |
| V3V 1Z2 |
| Canada |
| British Columbia Cancer Agency - Vancouver Cancer Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | B3H 1V7 | Canada |
| Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada |
| Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2L-4M1 | Canada |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |