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Melanoma (Skin)Phase 2NCT00104897

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

A Phase 2 study testing tanespimycin in people with Melanoma (Skin), run by Cancer Research UK at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
tanespimycin
How many people
25 participants
Where
2 sitesUnited Kingdom
Study dates
Mar 2005to Nov 2010
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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

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

Hepatic

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

Renal

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

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy

Chemotherapy

  • 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

Radiotherapy

  • 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

Surgery

  • Not specified

Other

  • 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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, CB2 2QQ

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

Conditions
Melanoma (Skin)
Being tested
tanespimycin
Keywords
recurrent melanoma, stage IV melanoma
Medical subject headings
Melanoma

What participants receive

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

  • tanespimycinDrug

What is being measured

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

  1. Disease stabilization at 6 months

Secondary outcomes (5)
  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

Timeline

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

  1. First posted4 Mar 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionNov 2010
  4. Study completionNov 2010

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
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104897
Sponsor's protocol ID
CRUK-PH2/049
Other IDs
CDR0000415352, NCI-6500
Status last verified
Mar 2008
First submitted
3 Mar 2005
Last updated
26 Jun 2013
Results posted
No

Publications

  • Pacey S, Gore M, Chao D, Banerji U, Larkin J, Sarker S, Owen K, Asad Y, Raynaud F, Walton M, Judson I, Workman P, Eisen T. A Phase II trial of 17-allylamino, 17-demethoxygeldanamycin (17-AAG, tanespimycin) in patients with metastatic melanoma. Invest New Drugs. 2012 Feb;30(1):341-9. doi: 10.1007/s10637-010-9493-4. Epub 2010 Aug 5.

    PubMed 20683637

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tanespimycin in people with Melanoma (Skin), run by Cancer Research UK at 2 sites in United Kingdom.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 26 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Disease stabilization at 6 months. 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 NCT00104897, which also lists 1 linked publication.

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 26 Jun 2013.

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