Skip to content

Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00109798
Enrollment
0
Registered
2005-05-04
Start date
2005-03-31
Completion date
2006-07-31
Last updated
2017-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Tumors, Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma

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. 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.

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 * 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.

Interventions

DRUGtemozolomide

Patient will take drug on day 1-5 of 28 day schedule

DRUGtopotecan hydrochloride

Patient will have IV on days 2-6 on a 28-day schedule

Sponsors

Baylor College of Medicine
CollaboratorOTHER
The Methodist Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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 1. Patients who are pregnant or breastfeeding, or females of childbearing potential not using adequate contraception. 2. Known allergy to temozolomide or topotecan. 3. Severe vomiting or other inability to administer medications orally. 4. 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.

Design outcomes

Primary

MeasureTime frame
Rate of complete radiologic response (CR)July 2006

Secondary

MeasureTime frame
Median overall survivalJuly 2006
Failure-free survivalJuly 2006
ToxicityJuly 2006
Overall response rate (CR and partial response)July 2006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026