17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma
Melanoma (Skin)
About this trial
This is an interventional treatment trial for Melanoma (Skin) focused on measuring recurrent melanoma, stage IV melanoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed malignant melanoma Metastatic (M1a, M1b, or M1c) disease Measurable disease by clinical exam, x-ray, CT scan, or MRI Must have documented disease progression at 2 time points separated by ≥ 6 months Pre-existing visceral lesions or the appearance of new visceral lesions allowed New skin disease amenable to surgery not allowed No primary brain tumors or brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy More than 3 months Hematopoietic WBC ≥ 3,000/mm^3 Platelet count ≥ 100,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 9.0 g/dL Hepatic Bilirubin normal ALT and AST ≤ 1.5 times upper limit of normal No chronic liver disease No known hepatitis B or C positivity Renal Creatinine < 130 mmol/L OR Creatinine clearance > 60 mL/min Cardiovascular No symptomatic congestive heart failure No myocardial infarction within the past 6 months No unstable angina pectoris No cardiac arrhythmia No transient ischemic attack No stroke or peripheral vascular disease Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception for 4 weeks before, during, and for 6 months after study participation No ongoing or active infection No diabetes mellitus with evidence of severe peripheral vascular disease or ulcers No history of allergy to eggs No known HIV positivity No psychiatric illness or social situation that would preclude study compliance No other uncontrolled illness No other malignancy except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy More than 4 weeks since prior immunotherapy Chemotherapy More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) Endocrine therapy More than 4 weeks since prior endocrine therapy Concurrent steroids allowed provided they are given at the lowest possible maintenance dose Radiotherapy More than 4 weeks since prior radiotherapy unless administered for palliative care Concurrent radiotherapy allowed provided it is administered as a single fraction for bone pain OR as indicated for palliative care Surgery Not specified Other Recovered from all prior therapy Alopecia allowed No concurrent therapeutic anticoagulation with warfarin Concurrent prophylactic warfarin for central line maintenance allowed provided INR is checked regularly until stable Concurrent low-molecular weight heparin allowed No other concurrent anticancer therapy No other concurrent investigational drugs
Sites / Locations
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
- Royal Marsden NHS Foundation Trust - Surrey