Methotrexate, Procarbazine, Lomustine, Dexamethasone, and Cytarabine in Treating Patients With Primary CNS Lymphoma - Article
Clinical Trial: Methotrexate, Procarbazine, Lomustine, Dexamethasone, and Cytarabine in Treating Patients With Primary CNS Lymphoma
This study is currently recruiting patients.
RATIONALE: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
|Condition||Treatment or Intervention||Phase|
|intraocular lymphoma |
primary central nervous system lymphoma
| Drug: cytarabine |
|Phase II |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy; Eye Cancer; Lymphoma; Neurologic Diseases
Study Type: Interventional
Study Design: Treatment
- Determine the toxicity and efficacy of methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine in patients with primary CNS lymphoma.
- Determine the ability to recruit adequate numbers of patients for this study.
- Compare progression-free and dementia-free survival with standard measures of overall survival, progression-free survival, disease-free survival, complete response rate, cognitive function, and quality of life of patients treated with this regimen.
- Determine the feasibility of conducting a future phase III study of this treatment regimen in these patients.
- Correlate neuropsychological outcomes with neuroimaging (MRI) outcomes in patients treated with this regimen.
OUTLINE: This is a nonrandomized, multicenter study.
- Patients receive methotrexate IV over 3 hours on days 1, 10, and 20 and intraventricularly or intrathecally (IT) over 5 minutes on days 1, 5, 10, and 15; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on days 1, 5, 10, and 15. Treatment repeats every 42 days for a total of 3 courses. Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam. Patients with stable or responding disease proceed to maintenance therapy.
- Patients receive methotrexate IV over 3 hours and IT over 5 minutes on day 1; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine intraventricularly or IT over 5 minutes on day 1. Treatment repeats every 42 days for a total of 5 courses. Patients with intraocular lymphoma also receive methotrexate intravitreally weekly for 1 month and then monthly for 1 year.
Quality of life is assessed at baseline, at 6 months, at the completion of treatment, every 6 months for 2 years, and then annually thereafter.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study within 3 years.
Ages Eligible for Study: 16 Years - 75 Years, Genders Eligible for Study: Both
- Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis
- Diagnosed within the past 90 days
- No systemic lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age
- 16 to 75
- ECOG 0-3 OR
- Karnofsky 40-100%
- Not specified
- WBC at least 2,500/mm^3
- Hematocrit at least 25% (transfusion allowed)
- Absolute granulocyte count at least 1,200/mm^3
- Platelet count at least 100,000/mm^3 OR at least lower limit of normal (transfusion independent)
- Bilirubin no greater than 2.0 times upper limit of normal
- Creatinine clearance at least 30 mL/min
- Adequate cardiac function to tolerate general anesthesia
- Adequate pulmonary function to tolerate general anesthesia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 2 months before and during study participation
- No other uncontrolled, clinically significant confounding medical condition within the past 30 days
- No known allergy to study agents
- HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy
- Not specified
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
- Single-agent methotrexate administered within the past 14 days allowed
- Not specified
- No prior cranial or spinal radiotherapy
Location and Contact Information
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States; Recruiting
Cancer Institute at Oregon Health and Science University, Portland, Oregon, 97239-3098, United States; Recruiting
Edward A. Neuwelt, MD, Principal Investigator, Oregon Health and Science University
Record last reviewed: December 2003
Last Updated: March 3, 2005
Record first received: December 10, 2003
ClinicalTrials.gov Identifier: NCT00074191
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005