Methylprednisolone Injection |
depMedalone; Depo-Medrol; Depoject; Depopred; Duralone; M-Prednisol; Medralone; Solu-Medrol |
Clinical Trial: Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin''s Lymphoma
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) December 2005
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Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin''''s lymphoma.
PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin''''s lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
| Primary Central Nervous System Lymphoma | Drug: methylprednisolone Drug: rituximab Drug: temozolomide Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: chemosensitization/potentiation Procedure: chemotherapy Procedure: monoclonal antibody therapy | Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Rituximab, Temozolomide, and Methylprednisolone in Patients With Recurrent Primary CNS Non-Hodgkin''''s Lymphoma
OBJECTIVES:
Primary
- Determine the response rate in patients with recurrent primary CNS non-Hodgkin''''s lymphoma treated with rituximab, temozolomide, and methylprednisolone.
Secondary
- Determine the overall and 6-month progression-free survival of patients treated with this regimen.
OUTLINE: Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 and oral temozolomide daily on days 1-7 and 15-21. After day 28, patients with stable disease or better proceed to consolidation therapy.
Patients receive oral temozolomide daily on days 1-5. Treatment repeats every 28 days for up to 6 courses. Patients achieving a complete remission proceed to maintenance therapy.
Patients receive methylprednisolone IV over 2 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 13.3 months.
Eligibility
DISEASE CHARACTERISTICS:
- Histologically confirmed primary CNS non-Hodgkin''''s lymphoma
- Recurrent disease
- Radiographical evidence of tumor progression by MRI or CT scan
- Steroid therapy must be stable for 5 days prior to scan
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- More than 8 weeks
Hematopoietic
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10 g/dL (transfusion allowed)
Hepatic
- SGOT < 2 times upper limit of normal (ULN)
- Bilirubin < 2 times ULN
- No active or latent hepatitis B infection
Renal
- Creatinine < 1.5 mg/dL OR
- Creatinine clearance ≥ 60 mL/min
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No uncontrolled significant medical illness that would preclude study treatment
- No active infection
- No concurrent disease that would dangerously alter drug metabolism or obscure toxicity
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 7 days since prior interferon or thalidomide
- No concurrent prophylactic filgrastim (G-CSF)
- No concurrent immunotherapy
Chemotherapy
- No prior temozolomide
- At least 14 days since prior methotrexate
- At least 21 days since prior procarbazine
- At least 42 days since prior nitrosoureas
- No other concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 7 days since prior tamoxifen
- No concurrent hormonal therapy
Radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- Recovered from all prior therapy
- At least 28 days since prior investigational agents
- At least 28 days since other prior cytotoxic therapy
- At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin) (radiosenitizers allowed)
- No other concurrent investigational drugs
Location and Contact Information
Lauren E. Abrey, MD, Study Chair, Memorial Sloan-Kettering Cancer Center
More Information
Clinical trial summary from the National Cancer Institute''''s PDQ® database
Last Updated: December 6, 2005
Record first received: November 3, 2005
ClinicalTrials.gov Identifier: NCT00248534
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10
Resources
- Depo-Medrol (Drug Digest)
- Depoject (Drug Digest)

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