Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Immunotherapy Combined With Chemotherapy Followed by Radiation Therapy and Chemotherapy in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | Any age | NCI | MSKCC-01146 NCT00059956 |
Objectives
- Determine the efficacy of induction immunochemotherapy comprising rituximab, methotrexate, procarbazine, and vincristine followed by reduced-dose radiotherapy and consolidation cytarabine in patients with newly diagnosed primary central nervous system lymphoma.
- Determine the 2-year and overall disease-free survival of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the acute treatment-related toxicity and safety of this regimen in these patients.
- Determine the initial response rate of patients treated with immunochemotherapy.
- Determine the relapse rate after complete response in patients treated with this regimen.
- Determine the neuro-cognitive outcome in patients treated with this regimen.
Entry Criteria
Disease Characteristics:
- Histologically confirmed primary non-Hodgkin's lymphoma by brain biopsy
- Patients who have an inconclusive biopsy or who are not a candidate for biopsy are eligible provided they have a typical cranial MRI or CT scan* AND meet at least 1 of the following criteria:
- Positive cerebrospinal fluid cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers
- Biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma
[Note: *Typical MRI or CT scan is defined as the presence of hypo-, iso-, or hyperdense parenchymal contrast-enhancing (usually homogeneously) mass lesion(s)]
- Patients who have an inconclusive biopsy or who are not a candidate for biopsy are eligible provided they have a typical cranial MRI or CT scan* AND meet at least 1 of the following criteria:
- HIV-1 negative
- Normal or negative pretreatment systemic evaluation including the following examinations:
- Bone marrow aspirate and biopsy
- CT scans of the chest, abdomen, and pelvis
Prior/Concurrent Therapy:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for CNS lymphoma
Endocrine therapy
- Not specified
Radiotherapy
- No prior cranial radiotherapy
Surgery
- Not specified
Other
- No citrus fruit, citrus fruit juices, or ascorbic acid supplements during and for 72 hours after methotrexate administration
Patient Characteristics:
Age
- Any age
Performance status
- Not specified
Life expectancy
- At least 8 weeks
Hematopoietic
- WBC at least 4,000/mm3
- Platelet count at least 100,000/mm3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal
Other
- Not pregnant
- Fertile patients must use effective contraception during and for 6 months after study participation
- No other active primary malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- No pre-existing immunodeficiency (e.g., renal transplantation recipient)
- Must maintain a tyramine-free diet (i.e., free of alcohol and certain cheeses) during procarbazine administration
Expected Enrollment
A total of 15-30 patients will be accrued for this study within 3 years.
Outcomes
Primary Outcome(s)Treatment related toxicity assessed by NCI CTC
Disease-free survival at 1 year
Response rate assessed radiographically every 2 months
Overall survival
Progression-free survival
Outline
This is a multicenter, pilot study.
- Induction immunochemotherapy: Patients receive rituximab IV over 5 hours on day 1 and methotrexate IV over 2 hours and vincristine IV over several minutes on day 2. Patients also receive oral procarbazine on days 2-8 during courses 1, 3, and 5. Treatment repeats every 2 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients with a partial response after 5 courses may receive an additional 2 courses.
- Radiotherapy: Beginning 3-5 weeks after completion of induction immunochemotherapy, patients undergo radiotherapy daily 5 days a week for 3-6 weeks.
- Consolidation chemotherapy: Patients receive cytarabine IV over 3 hours on days 1 and 2. Treatment repeats every 28 days for a total of 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
Trial Lead Organizations
Memorial Sloan-Kettering Cancer Center
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| Lauren Abrey, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients with Newly Diagnosed PCNSL | |
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| Trial Start Date | 2002-08-28 | |
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| Registered in ClinicalTrials.gov | NCT00059956 | |
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| Date Submitted to PDQ | 2003-03-12 | |
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| Information Last Verified | 2005-08-19 | |
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| NCI Grant/Contract Number | P30-CA08748 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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