A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed PCNSL
N/A
N/A
Both
Lymphoma
Trial Information
A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed PCNSL
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.
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.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.
Inclusion 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)
- 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
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- Not specified
Life expectancy
- At least 8 weeks
Hematopoietic
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance at least 50 mL/min
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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Treatment related toxicity assessed by NCI CTC
Safety Issue:
Yes
Principal Investigator
Lauren E. Abrey, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000298992
NCT ID:
NCT00059956
Start Date:
August 2002
Completion Date:
Related Keywords:
- Lymphoma
- primary central nervous system non-Hodgkin lymphoma
- Lymphoma
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15236 |
| Vermont Cancer Center at University of Vermont | Burlington, Vermont 05405-0075 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Kentuckiana Cancer Institute, PLLC | Louisville, Kentucky 40202 |
