Clinical trial · Interventional
SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
A Phase II Study of SB-715992 (NSC 727990) in Previously Untreated Patients With Metastatic or Recurrent Malignant Melanoma
NCT00095953CI-TRIAL-00010349completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ispinesib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response
- timeFrame
- 2 years
Secondary outcomes (3)
- measure
- Toxicity
- timeFrame
- 2 years
- measure
- Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is changed)
- timeFrame
- 2 years
- measure
- Molecular correlates on archival tissue, fresh tumor tissue, and peripheral blood mononuclear cells (PVMCs)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 therapiesReferences
Publications (1)
- RESULTLee 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