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

Primary Purpose

Melanoma (Skin), Metastatic Cancer

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
temozolomide
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma, tumors metastatic to brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Krankenhaus der Elisabethinen
  • Institut Jules Bordet
  • Hopital Universitaire Erasme
  • Universitair Ziekenhuis Antwerpen
  • Clinique Notre Dame de Grace
  • Onkologicka Klinka A Onkologicka Lab
  • CHU de Bordeaux - Hopital Pellegrin
  • CHU Ambroise Pare
  • Centre Hospital Regional Universitaire de Limoges
  • Hopital L'Archet - 2
  • Centre Eugene Marquis
  • Institut Gustave Roussy
  • Universitaetsklinikum Benjamin Franklin
  • Federal Armed Forces Hospital of Ulm - Department of Dermatology
  • Universitaets - Augenklinik - Erlangen
  • Georg August Universitaet
  • Haematologisch-Onkologische Praxis Altona
  • III Medizinische Klinik Mannheim
  • Eberhard Karls Universitaet
  • Universitaet Wuerzburg/Hautkrankheiten
  • Istituto Nazionale per la Ricerca sul Cancro
  • University Medical Center Nijmegen
  • Erasmus University Medical Center
  • Norwegian Radium Hospital
  • Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
  • UniversitaetsSpital
  • Addenbrooke's NHS Trust
  • St. James's Hospital
  • Royal Marsden NHS Trust
  • Christie Hospital N.H.S. Trust
  • Weston Park Hospital
  • Clatterbridge Centre for Oncology NHS Trust
  • Southend NHS Trust Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
September 20, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00020839
Brief Title
Temozolomide With or Without Radiation Therapy to the Brain in Treating Patients With Stage IV Melanoma That Is Metastatic to the Brain
Official Title
Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
April 2001 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

Brief 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. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin), Metastatic Cancer
Keywords
stage IV melanoma, recurrent melanoma, tumors metastatic to brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen C. Becker, MD, PhD
Organizational Affiliation
Universitaets-Hautklinik Wuerzburg
Official's Role
Study Chair
Facility Information:
Facility Name
Krankenhaus der Elisabethinen
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Hopital Universitaire Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Clinique Notre Dame de Grace
City
Gosselies
ZIP/Postal Code
6041
Country
Belgium
Facility Name
Onkologicka Klinka A Onkologicka Lab
City
Prague
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
CHU de Bordeaux - Hopital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Ambroise Pare
City
Boulogne Billancourt
ZIP/Postal Code
F-92104
Country
France
Facility Name
Centre Hospital Regional Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital L'Archet - 2
City
Nice
ZIP/Postal Code
F-06202
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
F-94805
Country
France
Facility Name
Universitaetsklinikum Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Federal Armed Forces Hospital of Ulm - Department of Dermatology
City
Blaustein
ZIP/Postal Code
D-89134
Country
Germany
Facility Name
Universitaets - Augenklinik - Erlangen
City
Erlangen
ZIP/Postal Code
D-91054
Country
Germany
Facility Name
Georg August Universitaet
City
Goettingen
ZIP/Postal Code
D-37075
Country
Germany
Facility Name
Haematologisch-Onkologische Praxis Altona
City
Hamburg
ZIP/Postal Code
D-22765
Country
Germany
Facility Name
III Medizinische Klinik Mannheim
City
Mannheim
ZIP/Postal Code
D-68305
Country
Germany
Facility Name
Eberhard Karls Universitaet
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitaet Wuerzburg/Hautkrankheiten
City
Wuerzburg
ZIP/Postal Code
D-97080
Country
Germany
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Norwegian Radium Hospital
City
Oslo
ZIP/Postal Code
N-0310
Country
Norway
Facility Name
Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa
City
Lisbon
ZIP/Postal Code
1093
Country
Portugal
Facility Name
UniversitaetsSpital
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland
Facility Name
Addenbrooke's NHS Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
St. James's Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Marsden NHS Trust
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 9BX
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 9BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology NHS Trust
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Southend NHS Trust Hospital
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom

12. IPD Sharing Statement

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

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