17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy, such as 17-N-allylamino-17-demethoxygeldanamycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well 17-N-allylamino-17-demethoxygeldanamycin works in treating patients with metastatic malignant melanoma.

Detailed Description
-----------------
OBJECTIVES: Primary Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic malignant melanoma. Determine the progression-free rate in patients treated with this drug. Secondary Determine the toxicity profile of this drug in these patients. Determine the duration of response in patients treated with this drug. Determine the survival of patients treated with this drug. OUTLINE: This is a nonrandomized, open-label, multicenter study. Patients receive 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses of treatment, disease response is assessed. Patients with stable or responding disease receive additional courses of treatment. After completion of study treatment, patients are followed at 28 days and then every 3 months thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 12-18 months.

Official Title
-----------------
A Phase II Trial to Assess the Activity of 17-allylamino, 17-demethoxygeldanamycin (17-AAG) in Patients With Metastatic (M1, M1b & M1c) Malignant Melanoma

Conditions
-----------------
Melanoma (Skin)

Intervention / Treatment
-----------------
* Drug: tanespimycin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tanespimycin|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease stabilization at 6 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity profile as measured by NCI CTCAE version 3 |  |  | 
| Response duration |  |  | 
| Survival |  |  | 
| Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1 |  |  | 
| B-RAF and RAS mutation status at baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recurrent melanoma, stage IV melanoma