Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00109798

Collaborator

Baylor College of Medicine (Other)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Central Nervous System Tumors Lymphoma	Drug: temozolomide Drug: topotecan hydrochloride	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Temozolomide, Topotecan Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule	Drug: temozolomide Patient will take drug on day 1-5 of 28 day schedule Other Names: Temodar Drug: topotecan hydrochloride Patient will have IV on days 2-6 on a 28-day schedule Other Names: Topotecan

Arm

Intervention/Treatment

Experimental: Temozolomide, Topotecan

Patient will take on days 1-5 of a 28-days schedule. Take Topotecan on days 2-6 of the 28 day schedule

Drug: temozolomide

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

Other Names:

Temodar

Drug: topotecan hydrochloride

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

Other Names:

Topotecan

Outcome Measures

Primary Outcome Measures

Rate of complete radiologic response (CR) [July 2006]

Secondary Outcome Measures

Median overall survival [July 2006]
Failure-free survival [July 2006]
Toxicity [July 2006]
Overall response rate (CR and partial response) [July 2006]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.