SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OBJECTIVES:
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Determine the efficacy of SB-715992, in terms of response rate, in patients with previously untreated metastatic or recurrent malignant melanoma.
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Determine the toxic effects of this drug in these patients.
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Determine the early progression rate and response duration in patients treated with this drug.
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Determine the pharmacokinetics of this drug in these patients.
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Correlate pharmacokinetics with safety and efficacy endpoints of this drug in these patients.
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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 Design
Outcome Measures
Primary Outcome Measures
- Response [2 years]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed malignant melanoma
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Previously untreated metastatic or recurrent disease
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Considered incurable by standard therapies
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Measurable disease
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At least one unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
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Bone metastases are not considered measurable disease
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Outside any previously irradiated area
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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
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No known CNS metastases
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CT scans or MRI are not required to rule out CNS metastases unless patient exhibits neurological signs or symptoms
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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
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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
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Platelet count ≥ 100,000/mm^3
Hepatic
-
Bilirubin normal
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AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
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No symptomatic congestive heart failure
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No unstable angina pectoris
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No cardiac arrhythmia
Other
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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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
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No other uncontrolled illness
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No ongoing or active infection
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No psychiatric illness or social situation that would preclude study participation
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No history of allergic reactions attributed to compounds of similar chemical or biological composition to SB-715992
PRIOR CONCURRENT THERAPY:
Biologic therapy
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At least 3 months since prior adjuvant immunotherapy
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No prior immunotherapy for metastatic or recurrent disease
Chemotherapy
- No prior chemotherapy, including regional therapy
Endocrine therapy
- Not specified
Radiotherapy
-
See Disease Characteristics
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At least 4 weeks since prior radiotherapy except for low-dose, non-myelosuppressive radiotherapy
Surgery
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See Disease Characteristics
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At least 4 weeks since prior major surgery
Other
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More than 28 days since prior investigational agents
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More than 14 days since prior and no concurrent use of any of the following CYP3A4 inhibitors or inducers:
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Clarithromycin
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Erythromycin
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Troleandomycin
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Itraconazole
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Ketoconazole
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Fluconazole (≤ 200 mg/day allowed)
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Voriconazole
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Nefazodone
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Fluvoxamine
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Verapamil
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Diltiazem
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Grapefruit juice
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Bitter orange
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Phenytoin
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Carbamazepine
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Phenobarbital
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Oxcarbazepine
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Rifampin
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Rifabutin
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Rifapentine
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Hypericum perforatum (St. John's wort)
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Modafinil
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At least 6 months since prior and no concurrent amiodarone
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No concurrent antiretroviral therapy for HIV-positive patients
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No other concurrent anticancer treatment
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No other concurrent investigational therapies
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | British Columbia Cancer Agency - Centre for the Southern Interior | Kelowna | British Columbia | Canada | V1Y 5L3 |
| 2 | Fraser Valley Cancer Centre at British Columbia Cancer Agency | Surrey | British Columbia | Canada | V3V 1Z2 |
| 3 | British Columbia Cancer Agency - Vancouver Cancer Centre | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 4 | Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 5 | Margaret and Charles Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 6 | Toronto Sunnybrook Regional Cancer Centre at Sunnybrook and Women's College Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 7 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2L-4M1 |
Sponsors and Collaborators
- NCIC Clinical Trials Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Christopher Lee, MD, BCCA - Fraser Valley Cancer Centre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I169
- CAN-NCIC-IND169
- CDR0000391842