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Status:

COMPLETED

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

Lead Sponsor:

Cancer Research UK

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Melanoma (Skin)

Eligibility:

All Genders

18+ years

Phase:

PHASE2

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 ...

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 p...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    November 1 2010

    Estimated Enrollment :

    25 Patients enrolled

    Trial Details

    Trial ID

    NCT00104897

    Start Date

    March 1 2005

    End Date

    November 1 2010

    Last Update

    June 26 2013

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    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