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


Phase 3
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin), Metastatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Juergen C. Becker, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Universitaets-Hautklinik Wuerzburg

Authority:

United States: Federal Government

Study ID:

EORTC-18981

NCT ID:

NCT00020839

Start Date:

April 2001

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • Metastatic Cancer
  • stage IV melanoma
  • recurrent melanoma
  • tumors metastatic to brain
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

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