Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma
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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 |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: methylprednisolone Drug: temozolomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma |
- Response rate assessed by MRI every 2 months [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival at 6 months [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2005 |
| Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
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: Induction therapy: 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.
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive cerebrospinal fluid cytology, or vitrectomy
- Recurrent disease
Measurable disease, define as bi-dimensionally measurable lesions with clearly defined margins by brain MRI or CT scan
- 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 active HIV 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
Contacts and Locations| United States, California | |
| UCSF Helen Diller Family Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, North Carolina | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| University of Texas Health Science Center at San Antonio | |
| San Antonio, Texas, United States, 78284-6220 | |
| United States, Wisconsin | |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792-6164 | |
| Study Chair: | Lauren E. Abrey, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided by National Cancer Institute (NCI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Michael Prados, Adult Brain Tumor Consortium |
| ClinicalTrials.gov Identifier: | NCT00248534 History of Changes |
| Other Study ID Numbers: | CDR0000445289, NABTC-05-01 |
| Study First Received: | November 3, 2005 |
| Last Updated: | October 11, 2012 |
| 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 Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate |
Temozolomide Rituximab Dacarbazine Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids |
ClinicalTrials.gov processed this record on May 16, 2013