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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Dacarbazine; Temozolomide

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