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

NCT00095953 | Completed Phase 2

• 3 other identifiers: I169CAN-NCIC-IND169CDR0000391842
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

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.

Conditions

Melanoma (Skin)

Keywords

recurrent melanoma; stage IV melanoma

Outcome Measures

Primary Outcomes (1)

• Response

  2 years

Secondary Outcomes (3)

• 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)

  2 years

Interventions

ispinesib DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

British Columbia Cancer Agency - Centre for the Southern Interior

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Fraser Valley Cancer Centre at British Columbia Cancer Agency

Surrey, British Columbia, V3V 1Z2, Canada

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2L-4M1, Canada

Location

Related Publications (1)

• 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.

  PMID: 17962907 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

ispinesib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christopher Lee, MD

  BCCA - Fraser Valley Cancer Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2004
• First Posted: November 9, 2004
• Study Start: November 1, 2004
• Primary Completion: September 1, 2006
• Study Completion: September 1, 2008
• Last Updated: May 17, 2013

Record last verified: 2011-09

Locations

CA (7)