Temozolomide and Topotecan in Treating Patients With Primary CNS Lymphoma - Full Text View

Sponsored by:	Baylor College of Medicine
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00109798

Purpose

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	Intervention	Phase
Lymphoma	Drug: temozolomide Drug: topotecan hydrochloride	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Temozolomide Topotecan hydrochloride Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Trial of Salvage Chemotherapy With Temozolomide in Combination With Topotecan for Primary CNS Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Rate of complete radiologic response (CR) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Median overall survival [ Designated as safety issue: No ]
Failure-free survival [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Overall response rate (CR and partial response) [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	March 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00109798

Locations

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine	Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trials Office - Dan L. Duncan Cancer Center at Baylor 713-798-1297

Sponsors and Collaborators

Baylor College of Medicine

Investigators

Study Chair:

Pamela Z. New, MD

Baylor College of Medicine

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000427313, BCM-H-16155
Study First Received:	May 3, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00109798
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

primary central nervous system lymphoma

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Topotecan
Lymphoproliferative Disorders

Temozolomide
Lymphoma
Central nervous system lymphoma, primary

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009