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

May 16, 2013 updated by: NCIC Clinical Trials Group

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

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.

Study Overview

Status

Completed

Conditions

Melanoma (Skin)

Intervention / Treatment

Drug: ispinesib

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 5L3
    - British Columbia Cancer Agency - Centre for the Southern Interior
  - Surrey, British Columbia, Canada, V3V 1Z2
    - Fraser Valley Cancer Centre at British Columbia Cancer Agency
  - Vancouver, British Columbia, Canada, V5Z 4E6
    - British Columbia Cancer Agency - Vancouver Cancer Centre
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 1V7
    - Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
- Ontario
  - Hamilton, Ontario, Canada, L8V 5C2
    - Margaret and Charles Juravinski Cancer Centre
  - Toronto, Ontario, Canada, M4N 3M5
    - Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre
- Quebec
  - Montreal, Quebec, Canada, H2L-4M1
    - Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response Time Frame: 2 years	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair: Christopher Lee, MD, BCCA - Fraser Valley Cancer Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (Estimate)