Methotrexate and Thiotepa in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00045539
First received: September 6, 2002
Last updated: March 13, 2010
Last verified: December 2005
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: leucovorin calcium Drug: methotrexate Drug: thiotepa |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Methotrexate and Thiotepa Chemotherapy for Patients With Newly Diagnosed Primary CNS Lymphoma |
Resource links provided by NLM:
Drug Information available for:
Thiotepa
Methotrexate
Leucovorin calcium
Methotrexate sodium
Levoleucovorin
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Complete radiographic response [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Duration of progression-free survival and overall survival [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Association of tumor BCL-6 expression with response [ Designated as safety issue: No ]
- Relationship among initial response to steroids, response to chemotherapy, and survival [ Designated as safety issue: No ]
| Study Start Date: | October 2002 |
OBJECTIVES:
- Determine the complete radiographic response in patients with newly diagnosed primary CNS lymphoma treated with methotrexate and thiotepa.
- Determine the duration of progression-free survival and overall survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine whether tumor expression of BCL-6 is associated with response to this chemotherapy regimen and survival of these patients.
- Describe the relationship between initial response to steroids (if administered), response to this chemotherapy regimen, and survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive thiotepa IV over 15 minutes on day 1. Patients also receive methotrexate IV over 4 hours on days 1 (8 hours after thiotepa) and 14. Beginning 24 hours after the start of methotrexate infusion, patients receive leucovorin calcium IV or orally every 6 hours until rescue is achieved. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving disappearance of enhancement of disease on MRI receive an additional 28-day course followed by maintenance therapy comprising thiotepa and methotrexate once a month for 11 courses.
Patients undergo neuro-ophthalmologic exams annually for 2 years.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A total of 23-39 patients will be accrued for this study within 8-20 months.
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045539
Locations
| United States, Alabama | |
| Comprehensive Cancer Center at University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3410 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
| Tampa, Florida, United States, 33612-9497 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| United States, Massachusetts | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Josephine Ford Cancer Center at Henry Ford Hospital | |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
Sponsors and Collaborators
Investigators
| Study Chair: | Tracy Batchelor, MD, MPH | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00045539 History of Changes |
| Other Study ID Numbers: | CDR0000256605, NABTT-2109, JHOC-NABTT-2109 |
| Study First Received: | September 6, 2002 |
| Last Updated: | March 13, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
primary central nervous system non-Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leucovorin Levoleucovorin Methotrexate Thiotepa Vitamin B Complex Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists |
ClinicalTrials.gov processed this record on May 16, 2013