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NCT00098774 · REGISTRY CONDITION SEARCH

Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS 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
COMPLETED
Registry last update
2016-07-06

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well rituximab given with combination chemotherapy works in treating patients with newly diagnosed primary CNS 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

Complete Response Rate After Remission Induction

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outcome · POSTED

4 Year Progression Free Rate

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outcome · POSTED

Change From Baseline in Mini-Mental Status Evaluation at 4 Months

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outcome · POSTED

4 Year Overall Survival Rate

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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 newly diagnosed primary CNS lymphoma confirmed by 1 of the following methods: * Brain biopsy or resection * Cerebrospinal fluid (CSF) cytology * Positive CSF cytology with or without measurable intracranial disease * No evidence of systemic non-Hodgkin's lymphoma * CT scan or MRI of the chest, abdomen, and pelvis AND bilateral bone marrow biopsy or unilateral biopsy with a 2cm core biopsy specimen that is negative for extracerebral source of lymphoma * Measurable contrast-enhancing disease by MRI of the brain and spine (plus gadolinium) unless CSF cytology positive * No evidence of pleural effusions or ascites PATIENT CHARACTERISTICS: Age * Any age Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 Hepatic * ALT and AST ≤ 2 times upper limit of normal * Bilirubin ≤ 2 mg/dL Renal * Creatinine clearance ≥ 50 mL/min Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after study participation * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Concurrent steroids for the management of symptoms related to lymphoma allowed Radiotherapy * No concurrent palliative radiotherapy Surgery * Not specified
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16 Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11 Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
    intervention Names
    1. Biological: filgrastim
    2. Biological: rituximab
    3. Drug: cytarabine
    4. Drug: etoposide
    5. Drug: leucovorin calcium
    6. Drug: methotrexate
    7. Drug: temozolomide
    label
    Intensive Combination Chemo & Immunotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Intensive Combination Chemo & Immunotherapy
    description
    5 mcg/kg subQ injection daily Day 14 until ANC \> or = 500 uL for 2 days or 1500 uL for 1 day (Cycle 6)
    name
    filgrastim
    other Names
    1. G-CSF
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Intensive Combination Chemo & Immunotherapy
    description
    375 mg/sq m IV infusion (max rate of 400 mg/hr) on Days 3, 10, 17, \& 24 of Cycle 1 nad Days 3 \& 10 of Cycle 2
    name
    rituximab
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Intensive Combination Chemo & Immunotherapy
    description
    2 g/sq m IV infusion over 2 hours q 12 hrs x 8 doses Days 1-4 of Cycle 6
    name
    cytarabine
    type
    DRUG
  4. arm Group Labels
    1. Intensive Combination Chemo & Immunotherapy
    description
    5 mg/kg IV infusion over 12 hrs q 12 hrs x 8 doses Days 1-4 of Cycle 6
    name
    etoposide
    type
    DRUG
  5. arm Group Labels
    1. Intensive Combination Chemo & Immunotherapy
    description
    100 mg/sq m IV infusion q 6 hrs starting 24 hrs after ea MTX dose until serum MTX \< or = 0.05uM Cycles 1-5.
    name
    leucovorin calcium
    type
    DRUG
  6. arm Group Labels
    1. Intensive Combination Chemo & Immunotherapy
    description
    8 g/sq m IV infusion over 4 hrs Days 1 \& 15 Cycles 1, 2, \& 3; Day 15 Cycle 4 and Day 1 Cycle 5.
    name
    methotrexate
    type
    DRUG
  7. arm Group Labels
    1. Intensive Combination Chemo & Immunotherapy
    description
    150 mg/sq m PO Days 7-11 Cycles 1-5.
    name
    temozolomide
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
47
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
    measure
    Complete Response Rate After Remission Induction
    time Frame
    4 months
secondary Outcomes
  1. description
    Percentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method. Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body
    measure
    4 Year Progression Free Rate
    time Frame
    4 years
  2. description
    Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.
    measure
    Change From Baseline in Mini-Mental Status Evaluation at 4 Months
    time Frame
    Baseline & month 4
  3. description
    Percentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method.
    measure
    4 Year Overall Survival Rate
    time Frame
    4 years
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. 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. Giving rituximab with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well rituximab given with combination chemotherapy works in treating patients with newly diagnosed primary CNS lymphoma.
detailed Description
OBJECTIVES: Primary * Determine the complete response rate after remission induction therapy with the combination of high-dose methotrexate (HDMTX), temozolomide, and rituximab at 4 months. Secondary * Determine the safety and feasibility of consolidation therapy comprising cytarabine and etoposide administered after induction therapy in these patients. * Determine the percentage of patients who achieve durable (complete and partial) remission when treated with this regimen. * Determine relapse-free survival after complete response in patients treated with this regimen. * Correlate molecular markers with outcome in patients treated with this regimen. * Determine the effects of this regimen on neurological function in these patients. OUTLINE: This is a multicenter study. * Induction Chemotherapy: All induction therapy courses repeat every 28 days. * Courses 1-3: Patients receive high-dose methotrexate IV over 4 hours on days 1 and 15, leucovorin calcium IV or orally every 6 hours beginning on days 2 and 16 and continuing until blood levels of methotrexate are in a safe range, and oral temozolomide on days 7-11. Patients also receive rituximab\* IV on days 3, 10, 17, and 24 of course 1 and days 3 and 10 of course 2 (total of 6 doses). NOTE: \*Patients diagnosed with T-cell primary CNS lymphoma do not receive rituximab. * Course 4: Patients receive oral temozolomide on days 7-11, high-dose methotrexate IV over 4 hours on day 15, and leucovorin calcium IV or orally every 6 hours beginning on day 16 and continuing until blood levels of methotrexate are in a safe range. Patients achieving a complete response or a complete response unconfirmed proceed to consolidation therapy. * Consolidation therapy I (course 5): Beginning 4 weeks after the start of course 4, patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin calcium IV or orally every 6 hours beginning on day 2 and continuing until blood levels of methotrexate are in a safe range, and oral temozolomide on days 7-11. * Consolidation therapy II (course 6): Beginning 3-5 weeks after the start of course 5, patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 12 hours twice daily on days 1-4 and filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning on day 14 and continuing until blood counts recover. Treatment continues in the absence of disease progression. After completion of study treatment, patients are followed periodically for 3 years. PROJECTED ACCRUAL: A total of 27-45 patients will be accrued for this study within 2-3 years.
Source references
references
  1. citation
    Rubenstein JL, Hsi ED, Johnson JL, Jung SH, Nakashima MO, Grant B, Cheson BD, Kaplan LD. Intensive chemotherapy and immunotherapy in patients with newly diagnosed primary CNS lymphoma: CALGB 50202 (Alliance 50202). J Clin Oncol. 2013 Sep 1;31(25):3061-8. doi: 10.1200/JCO.2012.46.9957. Epub 2013 Apr 8.
    pmid
    23569323
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      query disease state id
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    Preserved source evidence · Not medical advice