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Recurrent MelanomaPhase 2NCT00087386

Tanespimycin in Treating Patients With Stage III-IV Melanoma

A Phase 2 study testing tanespimycin and laboratory biomarker analysis in people with Recurrent Melanoma and Stage III Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tanespimycin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
Jun 2004to Feb 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 74Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
tanespimycin, laboratory biomarker analysis
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tanespimycinDrug

    Also called 17-AAG

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00087386
Study groupRoleWhat they receive
Treatment (tanespimycin)ExperimentalPatients 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.
Receives: Drug: tanespimycin; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate (complete and partial response)

    Measured: Up to 3 years

Secondary outcomes (2)

  1. Proportion of patients with stable disease

    Measured: At 1 year

  2. Frequency of toxicities

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2004 (estimated)
  2. Study startJun 2004
  3. Primary completionFeb 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00087386
Sponsor's protocol ID
NCI-2012-01453
Other IDs
04-056, NCI-6480, CDR0000374980, MSKCC-04056, N01CM62206
Status last verified
Apr 2013
First submitted
8 Jul 2004
Last updated
10 Apr 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tanespimycin and laboratory biomarker analysis in people with Recurrent Melanoma and Stage III Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 74 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (complete and partial response) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00087386.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.

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