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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104897
Recruitment Status : Completed
First Posted : March 4, 2005
Last Update Posted : June 26, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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
Melanoma (Skin) Drug: tanespimycin Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2005
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Primary Outcome Measures :
  1. Disease stabilization at 6 months

Secondary Outcome Measures :
  1. Toxicity profile as measured by NCI CTCAE version 3
  2. Response duration
  3. Survival
  4. Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1
  5. B-RAF and RAS mutation status at baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months


  • WBC ≥ 3,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 9.0 g/dL


  • Bilirubin normal
  • ALT and AST ≤ 1.5 times upper limit of normal
  • No chronic liver disease
  • No known hepatitis B or C positivity


  • Creatinine < 130 mmol/L OR
  • Creatinine clearance > 60 mL/min


  • 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


  • 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


Biologic therapy

  • More than 4 weeks since prior immunotherapy


  • 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


  • 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


  • Not specified


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00104897

United Kingdom
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Cancer Research UK
National Cancer Institute (NCI)
Study Chair: Timothy Eisen Cambridge University Hospitals NHS Foundation Trust

Publications of Results: Identifier: NCT00104897     History of Changes
Other Study ID Numbers: CRUK-PH2/049
CDR0000415352 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: March 2008

Keywords provided by National Cancer Institute (NCI):
recurrent melanoma
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas