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Phase II Treatment of Adults With Brain Metastases With Temodar


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase II Treatment of Adults With Brain Metastases With Temodar


OBJECTIVES:

- Determine the activity of temozolomide in patients with brain metastases.

- Determine the toxicity of this treatment in these patients.

OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs
breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs
other).

Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28
days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Metastatic lesions to the brain

- Must not require immediate radiotherapy

- If received prior radiotherapy, must have progressive disease

- Evaluable disease by CT scan or MRI

- Neurologically stable

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- More than 12 weeks

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 2.5 times ULN

- Alkaline phosphatase less than 2 times ULN

Renal:

- Blood urea nitrogen less than 1.5 times ULN

- Creatinine less than 1.5 times ULN

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other concurrent nonmalignant systemic disease

- No acute infection requiring treatment with IV antibiotics

- HIV negative

- No frequent vomiting or medical condition that would preclude oral medication
administration (e.g., partial bowel obstruction, inability to swallow)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent hematopoietic growth factors, including epoetin alfa

- No other concurrent biologic therapy

Chemotherapy:

- At least 4 weeks since prior chemotherapy, unless evidence of disease progression

- No other concurrent chemotherapy

Endocrine therapy:

- Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to
study

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease
progression

- No concurrent radiotherapy

Surgery:

- At least 3 weeks since prior surgery, unless evidence of disease progression, and
recovered

Other:

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

2114

NCT ID:

NCT00005954

Start Date:

August 2000

Completion Date:

June 2003

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult tumors metastatic to brain
  • Neoplasm Metastasis
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710