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

NCT00020839 | Terminated Phase 3

• 1 other identifier: EORTC-18981
• Study Type: interventional
• Target: 23
• Locations: 11 countries
• Sites: 33

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.

Conditions

Melanoma (Skin); Metastatic Cancer

Keywords

stage IV melanoma; recurrent melanoma; tumors metastatic to brain

Interventions

temozolomide DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (33)

Krankenhaus der Elisabethinen

Linz, 4020, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Hopital Universitaire Erasme

Brussels, 1070, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

Clinique Notre Dame de Grace

Gosselies, 6041, Belgium

Location

Onkologicka Klinka A Onkologicka Lab

Prague, 128 08, Czechia

Location

CHU de Bordeaux - Hopital Pellegrin

Bordeaux, 33076, France

Location

CHU Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Hopital L'Archet - 2

Nice, F-06202, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Institut Gustave Roussy

Villejuif, F-94805, France

Location

Universitaetsklinikum Benjamin Franklin

Berlin, D-12200, Germany

Location

Federal Armed Forces Hospital of Ulm - Department of Dermatology

Blaustein, D-89134, Germany

Location

Universitaets - Augenklinik - Erlangen

Erlangen, D-91054, Germany

Location

Georg August Universitaet

Göttingen, D-37075, Germany

Location

Haematologisch-Onkologische Praxis Altona

Hamburg, D-22765, Germany

Location

III Medizinische Klinik Mannheim

Mannheim, D-68305, Germany

Location

Eberhard Karls Universitaet

Tübingen, D-72076, Germany

Location

Universitaet Wuerzburg/Hautkrankheiten

Würzburg, D-97080, Germany

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

Erasmus University Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

Instituto Portugues de Oncologia de Francisco Gentil - Centro de Lisboa

Lisbon, 1093, Portugal

Location

UniversitaetsSpital

Zurich, CH-8091, Switzerland

Location

Addenbrooke's NHS Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

St. James's Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Marsden NHS Trust

London, England, SW3 6JJ, United Kingdom

Location

Christie Hospital N.H.S. Trust

Manchester, England, M20 9BX, United Kingdom

Location

Weston Park Hospital

Manchester, England, M20 9BX, United Kingdom

Location

Clatterbridge Centre for Oncology NHS Trust

Merseyside, England, CH63 4JY, United Kingdom

Location

Southend NHS Trust Hospital

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Brain Neoplasms

Interventions

Temozolomide; Radiotherapy

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Juergen C. Becker, MD, PhD

  Universitaets-Hautklinik Wuerzburg

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2001
• First Posted: January 27, 2003
• Study Start: April 1, 2001
• Primary Completion: May 1, 2003
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

FR (6); CZ (1); PT (1); DE (8); AU (1); GB (7); BE (4); NL (2); NO (1); IT (1); CH (1)