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

June 25, 2013 updated by: Cancer Research UK

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Cambridge, England, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease stabilization at 6 months

Secondary Outcome Measures

Outcome Measure
Survival
Response duration
Toxicity profile as measured by NCI CTCAE version 3
Pharmacodynamic effects as measured by western blot, magnetic resonance spectroscopy, and enzyme-linked immunosorbent assay (ELISA) during course 1
B-RAF and RAS mutation status at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Research UK

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Timothy Eisen, Cambridge University Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (Estimate)

March 4, 2005

Study Record Updates

Last Update Posted (Estimate)

June 26, 2013

Last Update Submitted That Met QC Criteria

June 25, 2013

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRUK-PH2/049
  • CDR0000415352 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-6500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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