Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma

NCT00045539 | Completed Phase 2

• 3 other identifiers: CDR0000256605NABTT-2109JHOC-NABTT-2109
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 9

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate and thiotepa, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining methotrexate with thiotepa in treating patients who have newly-diagnosed primary CNS lymphoma.

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Complete radiographic response

Secondary Outcomes (4)

• Duration of progression-free survival and overall survival

• Toxicity

• Association of tumor BCL-6 expression with response

• Relationship among initial response to steroids, response to chemotherapy, and survival

Interventions

leucovorin calcium DRUG

methotrexate DRUG

thiotepa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed primary CNS lymphoma * Confirmed by 1 of the following: * Brain biopsy or resection * CSF cytology * Positive cytology or immunohistochemical diagnosis of monoclonality and measurable intracranial tumor * Vitreal biopsy * Measurable and contrast-enhancing disease on the postoperative, pretreatment MRI or CT scan * No radiographic evidence of ascites or pleural effusions PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL * SGOT no greater than 4 times upper limit of normal Renal * Creatinine no greater than 2 mg/dL * Creatinine clearance at least 50 mL/min Other * Mini mental score of at least 15 * HIV negative * Able to achieve hydration * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ * No allergy to methotrexate * No serious infection * No medical illness that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior immunotherapy or biologic therapy for this disease Chemotherapy * No prior chemotherapy for this disease * No other concurrent chemotherapeutic agents Endocrine therapy * No prior hormonal therapy for this disease * Prior glucocorticoid therapy allowed Radiotherapy * No prior radiotherapy for this disease * No prior cranial irradiation Surgery * See Disease Characteristics Other * At least 1 week since prior salicylates, non-steroidal anti-inflammatory drugs, probenecid, folic acid, or sulfonamide medications * No other concurrent investigational agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• New Approaches to Brain Tumor Therapy Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (9)

Comprehensive Cancer Center at University of Alabama at Birmingham

Birmingham, Alabama, 35294-3410, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1096, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Leucovorin; Methotrexate; Thiotepa

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Aminopterin; Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring

Study Officials

• Tracy Batchelor, MD, MPH

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 6, 2002
• First Posted: January 27, 2003
• Study Start: October 1, 2002
• Study Completion: January 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2005-12

Locations

US (9)