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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NCIC Clinical Trials Group
• Collaborator: National Cancer Institute (NCI)

Criteria

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