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

Melanoma (Skin) Clinical Trial

Official title:

A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00095953
• Other study ID #: I169
• Secondary ID: CAN-NCIC-IND169C
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: May 16, 2013
• Start date: November 2004
• Est. completion date: September 2008

Study information

• Verified date: September 2011
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 2008
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Drug:
• ispinesib
SB-715992 will be given as a 1 hour intravenous infusion in a dose of 18 mg/m2 once every 3 weeks.

Locations

Country	Name	City	State
Canada	Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	Margaret and Charles Juravinski Cancer Centre	Hamilton	Ontario
Canada	British Columbia Cancer Agency - Centre for the Southern Interior	Kelowna	British Columbia
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Fraser Valley Cancer Centre at British Columbia Cancer Agency	Surrey	British Columbia
Canada	Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario
Canada	British Columbia Cancer Agency - Vancouver Cancer Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Canadian Cancer Trials Group	National Cancer Institute (NCI)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Lee CW, Bélanger 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 Can — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response		2 years	No
Secondary	Toxicity		2 years	Yes
Secondary	Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed)		2 years	No
Secondary	Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs)		2 years	No