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SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
ispinesib
Sponsored by
NCIC Clinical Trials Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Previously untreated metastatic or recurrent disease Considered incurable by standard therapies 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 Patients whose sole site of measurable disease is in a previously irradiated area are ineligible unless there is evidence of progression or new lesions documented in the irradiated field No known CNS metastases CT scans or MRI are not required to rule out CNS metastases unless patient exhibits neurological signs or symptoms Patients with a prior solitary brain metastasis surgically resected with no evidence of residual disease are eligible provided CT scan or MRI confirms no evidence of disease within the past 28 days Archival paraffin tumor specimen available PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years No other uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No history of allergic reactions attributed to compounds of similar chemical or biological composition to SB-715992 PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior adjuvant immunotherapy No prior immunotherapy for metastatic or recurrent disease Chemotherapy No prior chemotherapy, including regional therapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy except for low-dose, non-myelosuppressive radiotherapy Surgery See Disease Characteristics At least 4 weeks since prior major 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: Clarithromycin Erythromycin Troleandomycin Itraconazole Ketoconazole Fluconazole (≤ 200 mg/day allowed) Voriconazole Nefazodone Fluvoxamine Verapamil Diltiazem Grapefruit juice Bitter orange Phenytoin Carbamazepine Phenobarbital Oxcarbazepine Rifampin Rifabutin Rifapentine Hypericum perforatum (St. John's wort) Modafinil 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

Sites / Locations

  • British Columbia Cancer Agency - Centre for the Southern Interior
  • Fraser Valley Cancer Centre at British Columbia Cancer Agency
  • British Columbia Cancer Agency - Vancouver Cancer Centre
  • Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
  • Margaret and Charles Juravinski Cancer Centre
  • Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
  • Centre Hospitalier de l'Universite de Montreal

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Toxicity
Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed)
Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs)

Full Information

First Posted
November 9, 2004
Last Updated
May 16, 2013
Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00095953
Brief Title
SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Official Title
A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NCIC Clinical Trials Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
OBJECTIVES: Determine the efficacy of SB-715992, in terms of response rate, in patients with previously untreated metastatic or recurrent malignant melanoma. Determine the toxic effects of this drug in these patients. Determine the early progression rate and response duration in patients treated with this drug. Determine the pharmacokinetics of this drug in these patients. Correlate pharmacokinetics with safety and efficacy endpoints of this drug in these patients. Correlate β-tubulin and kinesin spindle protein expression in tumor tissue with clinical outcomes in patients treated with this drug. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ispinesib
Intervention Description
SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.
Primary Outcome Measure Information:
Title
Response
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Toxicity
Time Frame
2 years
Title
Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed)
Time Frame
2 years
Title
Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs)
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma Previously untreated metastatic or recurrent disease Considered incurable by standard therapies 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 Patients whose sole site of measurable disease is in a previously irradiated area are ineligible unless there is evidence of progression or new lesions documented in the irradiated field No known CNS metastases CT scans or MRI are not required to rule out CNS metastases unless patient exhibits neurological signs or symptoms Patients with a prior solitary brain metastasis surgically resected with no evidence of residual disease are eligible provided CT scan or MRI confirms no evidence of disease within the past 28 days Archival paraffin tumor specimen available PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute granulocyte count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal AST and ALT ≤ 2.5 times upper limit of normal (ULN) Renal Creatinine ≤ 1.5 times ULN Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumors with no evidence of disease for ≥ 5 years No other uncontrolled illness No ongoing or active infection No psychiatric illness or social situation that would preclude study participation No history of allergic reactions attributed to compounds of similar chemical or biological composition to SB-715992 PRIOR CONCURRENT THERAPY: Biologic therapy At least 3 months since prior adjuvant immunotherapy No prior immunotherapy for metastatic or recurrent disease Chemotherapy No prior chemotherapy, including regional therapy Endocrine therapy Not specified Radiotherapy See Disease Characteristics At least 4 weeks since prior radiotherapy except for low-dose, non-myelosuppressive radiotherapy Surgery See Disease Characteristics At least 4 weeks since prior major 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: Clarithromycin Erythromycin Troleandomycin Itraconazole Ketoconazole Fluconazole (≤ 200 mg/day allowed) Voriconazole Nefazodone Fluvoxamine Verapamil Diltiazem Grapefruit juice Bitter orange Phenytoin Carbamazepine Phenobarbital Oxcarbazepine Rifampin Rifabutin Rifapentine Hypericum perforatum (St. John's wort) Modafinil 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Lee, MD
Organizational Affiliation
BCCA - Fraser Valley Cancer Centre
Official's Role
Study Chair
Facility Information:
Facility Name
British Columbia Cancer Agency - Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Fraser Valley Cancer Centre at British Columbia Cancer Agency
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Margaret and Charles Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L-4M1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17962907
Citation
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.
Results Reference
result

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SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma

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