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Melanoma (Skin)Phase 3NCT00020839

Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain

A Phase 3 study testing temozolomide and radiation therapy in people with Melanoma (Skin) and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 11 countries.

Terminated

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

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin), Metastatic Cancer
What is being tested?
temozolomide and radiation therapy
Type of treatment
Surgery or procedure
How many people
23 participants
Where
33 sitesin 11 countries
Study dates
Apr 2001to May 2003
Phase
Phase 3
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 confirmed unresectable metastatic melanoma
  • Must have asymptomatic brain metastasis that is not amenable to surgery or stereotactic radiosurgery (gamma knife, Linac)
  • Must have concurrent visceral/soft tissue metastases
  • At least 1 site of measurable disease (not necessarily the brain metastasis)
  • Documented evidence of disease progression defined by 1 of the following conditions:
  • More than 25% increase in the size of at least 1 measurable lesion
  • Appearance of a new lesion
  • A significant increase in the size of nonmeasurable disease
  • No neurological symptoms, including signs of elevated intracranial pressure

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT less than 3 times ULN
  • Alkaline phosphatase less than 3 times ULN

Renal:

  • Urea less than 1.5 times ULN
  • Creatinine less than 1.5 times ULN

Other:

  • No frequent vomiting or medical condition (e.g., partial bowel obstruction) that would interfere with oral medication intake
  • No other prior or concurrent malignancy except surgically cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
  • No uncontrolled infection
  • HIV negative
  • No AIDS-related illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No psychological, familial, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Prior cytokine via isolated limb perfusion for local-regional melanoma allowed
  • No other prior cytokine for metastatic melanoma
  • No concurrent colony-stimulating factors, including epoetin alfa or filgrastim (G-CSF)
  • No other concurrent immunologic or biologic therapy

Chemotherapy:

  • Prior chemotherapy via isolated limb perfusion for local-regional melanoma allowed
  • No other prior chemotherapy for metastatic melanoma
  • No other concurrent chemotherapy

Endocrine therapy:

  • Concurrent corticosteroids allowed during radiotherapy (arm II only)
  • No concurrent hormonal therapy

Radiotherapy:

  • See Disease Characteristics
  • No other concurrent radiotherapy

Surgery:

  • See Disease Characteristics
  • Recovered from the effects of any prior major surgery

Other:

  • No other concurrent investigational drugs

Trial locations and contacts

33 sites in 11 countries.

33 sites in 11 countries

Germany8 sites
  • Universitaetsklinikum Benjamin Franklin

    Berlin, D-12200

  • Federal Armed Forces Hospital of Ulm - Department of Dermatology

    Blaustein, D-89134

  • Universitaets - Augenklinik - Erlangen

    Erlangen, D-91054

  • Georg August Universitaet

    Göttingen, D-37075

  • Haematologisch-Onkologische Praxis Altona

    Hamburg, D-22765

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Eberhard Karls Universitaet

    Tübingen, D-72076

  • Universitaet Wuerzburg/Hautkrankheiten

    Würzburg, D-97080

Other trials in Germany

United Kingdom7 sites
  • Addenbrooke's NHS Trust

    Cambridge, England, CB2 2QQ

  • St. James's Hospital

    Leeds, England, LS9 7TF

  • Royal Marsden NHS Trust

    London, England, SW3 6JJ

  • Christie Hospital N.H.S. Trust

    Manchester, England, M20 9BX

  • Weston Park Hospital

    Manchester, England, M20 9BX

  • Clatterbridge Centre for Oncology NHS Trust

    Merseyside, England, CH63 4JY

  • Southend NHS Trust Hospital

    Westcliff-on-Sea, England, SS0 0RY

Other trials in United Kingdom

France6 sites
  • CHU de Bordeaux - Hopital Pellegrin

    Bordeaux, 33076

  • CHU Ambroise Pare

    Boulogne-Billancourt, F-92104

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Hopital L'Archet - 2

    Nice, F-06202

  • Centre Eugene Marquis

    Rennes, 35042

  • Institut Gustave Roussy

    Villejuif, F-94805

Other trials in France

Belgium4 sites
  • Institut Jules Bordet

    Brussels, 1000

  • Hopital Universitaire Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • Clinique Notre Dame de Grace

    Gosselies, 6041

Other trials in Belgium

Netherlands2 sites
  • University Medical Center Nijmegen

    Nijmegen, NL-6500 HB

  • Erasmus University Medical Center

    Rotterdam, 3075 EA

Other trials in Netherlands

Austria1 site
  • Krankenhaus der Elisabethinen

    Linz, 4020

Other trials in Austria

Czechia1 site
  • Onkologicka Klinka A Onkologicka Lab

    Prague, 128 08

Other trials in Czechia

Italy1 site
  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa (Genova), 16132

Other trials in Italy

Norway1 site
  • Norwegian Radium Hospital

    Oslo, N-0310

Other trials in Norway

Portugal1 site
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

    Lisbon, 1093

Other trials in Portugal

Switzerland1 site
  • UniversitaetsSpital

    Zurich, CH-8091

Other trials in Switzerland

About this study

Official title: Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy is more effective with or without radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy to the brain in treating patients who have stage IV melanoma with asymptomatic brain metastases.

Read the detailed description

OBJECTIVES:

  • Compare the efficacy of temozolomide with or without radiotherapy in terms of overall survival in patients with stage IV melanoma with asymptomatic brain metastases.
  • Compare the time to appearance of neurological symptoms in patients treated with these regimens.
  • Compare the progression-free survival of patients treated with these regimens.
  • Compare the quality of life and quality-adjusted survival of patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to LDH levels (less than 225 U/L vs 225 U/L or more), concurrent metastases (visceral vs soft tissue), and participating center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral temozolomide once daily on days 1-5. Treatment continues every 4 weeks for a maximum of 1 year in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive temozolomide as in arm I and whole brain radiotherapy on days 8-12 and 15-19 during the first course of chemotherapy.

Quality of life is assessed before beginning each course and then every 4 weeks after completion of study drug.

Patients are followed every 4 weeks.

PROJECTED ACCRUAL: A total of 250 patients will be accrued for this study within 2 years.

Being tested
temozolomide, radiation therapy
Keywords
stage IV melanoma, recurrent melanoma, tumors metastatic to brain
Medical subject headings
Melanoma, Neoplasm Metastasis, Brain Neoplasms

What participants receive

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

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001
  3. Primary completionMay 2003

Why it stopped: low accrual

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 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00020839
Sponsor's protocol ID
EORTC-18981
Other IDs
EORTC-18981
Status last verified
Sep 2012
First submitted
11 Jul 2001
Last updated
24 Sep 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing temozolomide and radiation therapy in people with Melanoma (Skin) and Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 11 countries.

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: stopped early, as of the sponsor's last update on 24 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Germany, United Kingdom, France, Belgium, Netherlands and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 (reason given: low accrual). 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.

Where can I read the original study information?
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 24 Sep 2012.

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