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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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) Metastatic Cancer |
Drug: temozolomide Radiation: radiation therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Temozolomide Versus Temozolomide + Whole Brain Radiation In Stage IV Melanoma Patients With Asymptomatic Brain Metastases |
| Enrollment: | 23 |
| Study Start Date: | April 2001 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Show 33 Study Locations| Study Chair: | Juergen C. Becker, MD, PhD | Universitaets-Hautklinik Wuerzburg |
More Information
Additional Information:
No publications provided
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00020839 History of Changes |
| Other Study ID Numbers: | EORTC-18981, EORTC-18981 |
| Study First Received: | July 11, 2001 |
| Last Updated: | September 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
|
stage IV melanoma recurrent melanoma tumors metastatic to brain |
Additional relevant MeSH terms:
|
Melanoma Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |
Neoplastic Processes Pathologic Processes Temozolomide Dacarbazine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013