Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | March 2005 |
Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide and topotecan, work in different
ways to stop the growth of cancer cells, either by killing the cells or by stopping them
from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer
cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with
topotecan works in treating patients with primary CNS lymphoma.
OBJECTIVES:
Primary
- Determine the complete radiologic response rate in patients with primary CNS lymphoma
treated with salvage chemotherapy comprising temozolomide and topotecan.
Secondary
- Determine the median and failure-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the overall response rate in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive oral temozolomide once daily on days 1-5 and topotecan IV over 30 minutes
once daily on days 2-6. Treatment repeats every 28 days for 6-8 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year, every
4 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 6-25 patients will be accrued for this study.
DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS lymphoma at initial diagnosis
- Measurable tumor by radiography
- Failed* OR is not a candidate for first-line high-dose systemic methotrexate-based
chemotherapy with or without radiotherapy NOTE: *Failure is defined as relapse,
progression, or failure to achieve a complete response
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 50-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
Hepatic
- SGOT and SGPT ≤ 3 times upper limit of normal
- Bilirubin ≤ 2.0 mg/dL
Renal
- Creatinine clearance > 40 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No known allergy to temozolomide or topotecan
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or stage I or II cancer in complete remission
- No other major medical illness or psychiatric impairment that would preclude study
participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent prophylactic growth factors
Chemotherapy
- See Disease Characteristics
- At least 6 weeks since prior nitrosoureas
- At least 2 weeks since prior methotrexate
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- Not specified
Other
- Recovered from all prior therapy
- At least 4 weeks since prior non-nitrosourea cytotoxic drugs (except methotrexate)
- At least 4 weeks since prior systemic investigational agents
- At least 2 weeks since prior non-cytotoxic antitumor drugs
- No other concurrent antitumor therapy
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