Suspended

Phase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

tanespimycin

+ laboratory biomarker analysis

DrugOther
Who is being recruted

Melanoma+8

+ Neoplasms

+ Neoplasms by Histologic Type

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2004

Actual date on which the first participant was enrolled.

PRIMARY OBJECTIVES: 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.

Official TitlePhase II Trial of 17-N-allylamino-17-demethoxy Geldanamycin (17-AAG, NSC #330507) Diluted in EPL Diluent (NSC #704057) in Metastatic Melanoma Patients 
NCT00087386
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

MelanomaNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueSkin DiseasesSkin NeoplasmsNeuroectodermal TumorsNevi and MelanomasNeuroendocrine Tumors

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Memorial Sloan-Kettering Cancer Center

New York, United StatesSee the location
SuspendedOne Study Center