Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases - Full Text View

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00049361

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. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors Unspecified Adult Solid Tumor, Protocol Specific	Drug: temozolomide Drug: thalidomide Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Thalidomide Temozolomide

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Primary Outcome Measures:

Overall median survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Radiographic response rate as assessed by MRI and RECIST one-dimensional criterion at 1 month, 3 months, and every 3 months thereafter [ Designated as safety issue: No ]
Median time to tumor progression [ Designated as safety issue: No ]
Median time to neurologic response and progression [ Designated as safety issue: No ]
Cause of death at median time [ Designated as safety issue: No ]
Quality of life as assessed by FACT-BT, FACT-F, and Beck Depression Inventory at 1 month, 3 months, and every 3 months thereafter [ Designated as safety issue: No ]
Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0 for up to 90 days [ Designated as safety issue: Yes ]

Study Start Date:

January 2004

Detailed Description:

OBJECTIVES:

Determine the overall median survival time of patients with newly diagnosed brain metastases treated with whole-brain radiotherapy in combination with thalidomide and temozolomide.
Determine the radiographic response rate, median time to tumor progression, and median time to neurologic response and progression in patients treated with this regimen.
Determine the cause of death of patients treated with this regimen.
Determine the toxicity of this regimen in these patients.
Assess quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy daily 5 days a week for 3 weeks. Beginning on the day before the first radiation treatment, patients receive oral thalidomide once daily and oral temozolomide once daily for 21 days. Patients continue to receive thalidomide daily for up to 2 years in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 1 and 3 months after completing radiotherapy, and then every 3 months thereafter.

Patients are followed at 1 and 3 months and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study within 10 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed extracranial primary malignancy or brain metastases
At least 1 brain metastasis with at least 1 unresected lesion that is measurable by contrast-enhanced MRI
No evidence of spinal drop metastases or spread to noncontiguous meninges
No lymphoma, small cell lung cancer, or germ cell tumor

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 70-100%

Life expectancy

At least 4 months

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 mg/dL
SGPT and/or SGOT no greater than 2 times upper limit of normal

Renal

Creatinine no greater than 1.5 mg/dL
BUN no greater than 25 mg/dL

Other

Able to be regularly followed
No sensory neuropathy greater than grade 2
No other major medical illnesses that would preclude study
No neurologic or psychiatric impairments that would preclude study
No active infection
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use at least 1 highly effective and 1 additional effective method of contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
No other concurrent chemotherapy during and for 4 weeks after study

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy to head or neck
No prior stereotactic radiosurgery
Concurrent radiotherapy to extracranial sites of underlying malignancy allowed

Surgery

Prior craniotomy allowed if completed within the past 10-28 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049361

Locations

United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1030
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Volker W. Stieber, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00049361 History of Changes
Other Study ID Numbers:	CDR0000258057, CCCWFU-91102, NCI-5883
Study First Received:	November 12, 2002
Last Updated:	August 20, 2009
Health Authority:	United States: Federal Government

Keywords provided by Wake Forest University Baptist Medical Center:

adult tumors metastatic to brain
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:

Neoplasm Metastasis
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Nervous System Diseases
Thalidomide
Temozolomide
Dacarbazine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012