Tanespimycin in Treating Patients With Stage III-IV 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: NCT00087386
Recruitment Status : Terminated
First Posted : July 12, 2004
Last Update Posted : April 10, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This phase II trial is studying how well tanespimycin works in treating patients with stage III or stage IV melanoma. Antitumor antibiotics such as tanespimycin may stop the growth of melanoma by stopping blood flow to the tumor.

Condition or disease Intervention/treatment Phase
Recurrent Melanoma Stage III Melanoma Stage IV Melanoma Drug: tanespimycin Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. Determine if treatment with 17-AAG results in measurable anti-tumor effects and calculate the proportion of clinical responses.

II. Test the hypothesis that treatment with 17-AAG can disrupt the MAPK pathway by depleting intra-tumor stores of RAF kinases and/or downstream proteins such as phospho-ERK, CDK4 and cyclin D1.

III. Determine if either of these effects correlates with the presence of mutated BRAF within the melanoma tumor.

OUTLINE: This is a multicenter study. Patients are stratified according to presence of BRAF mutation in tumor (yes vs no).

Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients
Study Start Date : June 2004
Actual Primary Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (tanespimycin)
Patients receive tanespimycin IV over 1-6 hours once weekly for 6 weeks. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.
Drug: tanespimycin
Given IV
Other Name: 17-AAG
Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Response rate (complete and partial response) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Proportion of patients with stable disease [ Time Frame: At 1 year ]
  2. Frequency of toxicities [ Time Frame: Up to 3 years ]

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

Inclusion Criteria:

  • Histologically or cytologically confirmed melanoma

    • Stage III or IV disease
  • No primary melanoma of the choroid or mucosa
  • Measurable disease

    • At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
  • Tumor amenable to biopsy (for the first 10 patients in each stratum only)

    • Patients must have measurable disease in addition to the tumor(s) to be biopsied
  • No brain or epidural metastases

    • Completely resected solitary brain metastases allowed provided patient has been free of CNS metastases for >= 6 months
  • Performance status - Karnofsky 60-100%
  • Performance status - ECOG 0-2
  • More than 3 months
  • Absolute neutrophil count >= 1,500/mm^3
  • Platelet count >= 100,000/mm^3
  • WBC >= 3,000/mm^3
  • AST and ALT =< 2.5 times upper limit of normal
  • Creatinine normal
  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No history of myocardial infarction
  • No history of prolonged QTc interval
  • No active ischemic heart disease within the past 12 months
  • No uncontrolled dysrhythmia or dysrhythmias requiring medication
  • No congenital prolonged QT syndrome
  • No left bundle branch block
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to 17-N-allylamino-17-demethoxygeldanamycin (17-AAG)
  • No prior serious allergic reaction to eggs
  • No other uncontrolled illness
  • No active or ongoing infection requiring systemic antimicrobial treatment
  • No psychiatric illness or social situation that would preclude study compliance
  • No more than 1 prior chemotherapy regimen for metastatic melanoma

    • Prior vaccines, cytokines, or interferon alfa is not considered prior therapy unless administered with a chemotherapy drug
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior radiotherapy dose =< 3,000 cGy to fields including substantial marrow
  • More than 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy field that included the heart (e.g., mantle)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent medications that may prolong the QTc interval
  • No other concurrent anticancer therapy
  • No other concurrent investigational agents
  • No concurrent treatment with any of the following medications or herbal remedies:

    • Inhibitors of CYP3A4:

      • Fluconazole
      • Itraconazole
      • Ketoconazole
      • Macrolide antibiotics (azithromycin, clarithromycin, erythromycin, or troleandomycin)
      • Midazolam
      • Nifedipine
      • Verapamil
      • Diltiazem
      • Terfenadine
      • Cyclosporine
      • Cisapride
    • Inducers of CYP3A4:

      • Carbamazepine
      • Phenobarbital
      • Phenytoin
      • Rifampin
    • Herbal extracts and tinctures with CYP3A4 inhibitory activity:

      • Hydrastis canadensis (goldenseal)
      • Hypericum perforatum (St. John's wort)
      • Uncaria tomentosa (cat's claw)
      • Echinacea angustifolia roots
      • Trifolium pratense (wild cherry)
      • Matricaria chamomilla (chamomile)
      • Glycyrrhiza glabra (licorice)
      • Dillapiol
      • Hypericin
      • Naringin
  • No other concurrent herbal extracts

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): NCT00087386

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Paul Chapman Memorial Sloan Kettering Cancer Center

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00087386     History of Changes
Other Study ID Numbers: NCI-2012-01453
N01CM62206 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2004    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013

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