Status:
WITHDRAWN
Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma
Lead Sponsor:
The Methodist Hospital Research Institute
Collaborating Sponsors:
Baylor College of Medicine
Conditions:
Central Nervous System Tumors
Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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. Giv...
Detailed Description
OBJECTIVES: Primary * Determine the complete radiologic response rate in patients with primary CNS lymphoma treated with salvage chemotherapy comprising temozolomide and topotecan. Secondary * Det...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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
- EXCLUSION CRITERA
- Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception.
- Known allergy to temozolomide or topotecan.
- Severe vomiting or other inability to administer medications orally.
- Major medical illnesses or psychiatric impairment that in the investigator's opinion will prevent administration or completion of the protocol therapy and/or will interfere with follow-up.
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00109798
Start Date
March 1 2005
End Date
July 1 2006
Last Update
September 19 2017
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