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

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Cancer Research UK
• Collaborator: National Cancer Institute (NCI)

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