Suspended

Tanespimycin in Treating Patients With Stage III-IV Melanoma

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What is being tested

tanespimycin

+ laboratory biomarker analysis
Drug
Other
Who is being recruted

Recurrent Melanoma

+ Stage III Melanoma
+ Stage IV Melanoma
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: April 10, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

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. 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 
Principal SponsorNational Cancer Institute (NCI)
Last updated: April 10, 2013
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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Recurrent Melanoma
Stage III Melanoma
Stage IV Melanoma
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 CenterNew York, United StatesSee the location
SuspendedOne Study Center