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A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase II Study Of Whole-Brain Radiation Therapy With Thalidomide And Temozolomide In Patients With Newly Diagnosed Brain Metastases


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall median survival

Safety Issue:

No

Principal Investigator

Volker W. Stieber, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000258057

NCT ID:

NCT00049361

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Unspecified Adult Solid Tumor, Protocol Specific
  • adult tumors metastatic to brain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - GreenvilleGreenville, South Carolina  29615