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NCT00248534 · REGISTRY CONDITION SEARCH

Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin's Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2018-09-04

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Percentage of Participants With Objective Response

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outcome · POSTED

Number of Participants Alive at 3 Years

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outcome · POSTED

1 Year Overall Survival Rate

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outcome · POSTED

6-month Progression-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    IV Rituximab 750mg/m2 single infusion every week for up to 4 weeks. Induction: Rituximab (750mg/m2) Day 1, 8, 15 and 22 and Temozolomide \[TMZ\] (150mg/m2) days 1-7 and 15-21, followed by six cycles of consolidation TMZ 150-200mg/m2 x5/28days, followed by maintenance with methylprednisolone (1g IV every 28days) until progression
    intervention Names
    1. Biological: rituximab
    2. Drug: methylprednisolone
    3. Drug: temozolomide
    label
    IV Rituximab
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. IV Rituximab
    description
    given IV days 1,8, 15 and 22
    name
    rituximab
    type
    BIOLOGICAL
  2. arm Group Labels
    1. IV Rituximab
    description
    2hr IV every 28 days post consolidation cycles of Temozolomide (TMZ) (6 cycles TMZ = Consolidation cycles)
    name
    methylprednisolone
    type
    DRUG
  3. arm Group Labels
    1. IV Rituximab
    description
    Induction Days 1-7 and 15-21 (150mg/m2 PO) Consolidation days 1-5 every 28 days X 6 cycles
    name
    temozolomide
    other Names
    1. TMZ
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
16
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Objective response rate of the combination of Rituximab and TMZ
    measure
    Percentage of Participants With Objective Response
    time Frame
    2 months
secondary Outcomes
  1. description
    The intent was to measure Median Overall Survival at 3 years, however only one participant was analyzable at this time point. Therefore, the number of participants who survived is reported instead.
    measure
    Number of Participants Alive at 3 Years
    time Frame
    3 years
  2. measure
    1 Year Overall Survival Rate
    time Frame
    1 year
  3. description
    Scan at 6 months Complete response: Complete disappearance of all tumor on MRI scan, off all glucocorticoids with stable or improving neurological exam minimum of 4 wks Partial response: Greater than or equal 50% reduction in tumor size on MRI, on sable or decreasing glucocorticoids with stable or improving neurological exam for a minimum of 4 wks. Progressive disease: Progressive neurological abnormalities not explained by other causes or greater than 25% increase in size of tumor or if new lesion. Stable disease: Clinical status and MRI does not qualify for complete response, partial response or progression
    measure
    6-month Progression-free Survival
    time Frame
    6 months
Full study description
brief Summary
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.
detailed Description
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.
Source references
references
  1. citation
    Nayak L, Abrey LE, Drappatz J, et al.: Multicenter phase II trial of temozolomide (TMZ) and rituximab (RIT) for recurrent primary CNS lymphoma (PCNSL): North American Brain Tumor Consortium (NABTC) study 05-01. [Abstract] J Clin Oncol 29 (Suppl 15): A-2039, 2011.
    type
    RESULT
  2. citation
    Nayak L, Abrey LE, Drappatz J, Gilbert MR, Reardon DA, Wen PY, Prados M, Deangelis LM, Omuro A; North American Brain Tumor Consortium. Multicenter phase II study of rituximab and temozolomide in recurrent primary central nervous system lymphoma. Leuk Lymphoma. 2013 Jan;54(1):58-61. doi: 10.3109/10428194.2012.698736. Epub 2012 Jul 9.
    pmid
    22656234
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      payload
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      id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT00248534
        start
        0
      offset unit
      unicode_code_points
      query cond
      Primary Central Nervous System Lymphoma
      query disease state id
      ds-primary-central-nervous-system-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-primary-central-nervous-system-lymphoma-000.json
      source file sha256
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      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
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    Preserved source evidence · Not medical advice