17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic Malignant Melanoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OBJECTIVES:
Primary
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Determine the antitumor activity of 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) in patients with metastatic malignant melanoma.
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Determine the progression-free rate in patients treated with this drug.
Secondary
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Determine the toxicity profile of this drug in these patients.
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Determine the duration of response in patients treated with this drug.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Disease stabilization at 6 months []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed malignant melanoma
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Metastatic (M1a, M1b, or M1c) disease
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Measurable disease by clinical exam, x-ray, CT scan, or MRI
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Must have documented disease progression at 2 time points separated by ≥ 6 months
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Pre-existing visceral lesions or the appearance of new visceral lesions allowed
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New skin disease amenable to surgery not allowed
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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
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WBC ≥ 3,000/mm^3
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Platelet count ≥ 100,000/mm^3
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Absolute neutrophil count ≥ 1,500/mm^3
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Hemoglobin ≥ 9.0 g/dL
Hepatic
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Bilirubin normal
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ALT and AST ≤ 1.5 times upper limit of normal
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No chronic liver disease
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No known hepatitis B or C positivity
Renal
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Creatinine < 130 mmol/L OR
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Creatinine clearance > 60 mL/min
Cardiovascular
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No symptomatic congestive heart failure
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No myocardial infarction within the past 6 months
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No unstable angina pectoris
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No cardiac arrhythmia
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No transient ischemic attack
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No stroke or peripheral vascular disease
Other
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception for 4 weeks before, during, and for 6 months after study participation
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No ongoing or active infection
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No diabetes mellitus with evidence of severe peripheral vascular disease or ulcers
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No history of allergy to eggs
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No known HIV positivity
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No psychiatric illness or social situation that would preclude study compliance
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No other uncontrolled illness
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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
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More than 4 weeks since prior endocrine therapy
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Concurrent steroids allowed provided they are given at the lowest possible maintenance dose
Radiotherapy
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More than 4 weeks since prior radiotherapy unless administered for palliative care
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Concurrent radiotherapy allowed provided it is administered as a single fraction for bone pain OR as indicated for palliative care
Surgery
- Not specified
Other
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Recovered from all prior therapy
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Alopecia allowed
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No concurrent therapeutic anticoagulation with warfarin
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Concurrent prophylactic warfarin for central line maintenance allowed provided INR is checked regularly until stable
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Concurrent low-molecular weight heparin allowed
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No other concurrent anticancer therapy
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No other concurrent investigational drugs
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust | Cambridge | England | United Kingdom | CB2 2QQ |
| 2 | Royal Marsden NHS Foundation Trust - Surrey | Sutton | England | United Kingdom | SM2 5PT |
Sponsors and Collaborators
- Cancer Research UK
- National Cancer Institute (NCI)
Investigators
- Study Chair: Timothy Eisen, Cambridge University Hospitals NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRUK-PH2/049
- CDR0000415352
- NCI-6500