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NCT00335140 · REGISTRY CONDITION SEARCH

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System 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
2023-07-03

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (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 - Locally Reviewed

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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
Inclusion criteria: * Histologically confirmed non-Hodgkin's lymphoma by brain biopsy * Patients with inconclusive biopsy or patients who are not candidates for biopsy must have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria: * Positive cerebrospinal fluid cytology for lymphoma OR a monoclonal lymphoid population as defined by cell surface markers or immunoglobulin gene rearrangement studies * Biopsy-proven involvement of the vitreous or uvea if cells are apparent in the posterior chamber or vitreous by ophthalmological examination * Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by pretreatment MRI/CT scan * Meningeal or vitreous involvement constitutes evaluable but not measurable disease * If an excisional, rather than a needle biopsy was done, measurable disease must be present on a postoperative scan (not a PET-CT scan) * ECOG performance status 0-3 * Absolute granulocyte count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ upper limit of normal (ULN) * SGOT ≤ 2.0 times ULN * Creatinine clearance ≥ 50 mL/min * Negative pregnancy test * Fertile patients must use effective contraception Exclusion criteria: * Pregnant or nursing * HIV-1 positivity * Other malignancy within the past 5 years except basal cell skin cancer or any carcinoma in situ * Pre-existing immunodeficiency * Hepatitis B surface antigen positivity * Systemic lymphoma (as determined by pre-registration CT scans and physical examination) * Prior chemotherapy or radiotherapy for primary central nervous system lymphoma * Prior organ or bone marrow transplantation
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
    intervention Names
    1. Biological: Rituximab
    2. Drug: Cytarabine
    3. Drug: Dexamethasone
    4. Drug: Leucovorin
    5. Drug: Methotrexate
    6. Drug: Procarbazine
    7. Drug: Vincristine
    label
    Rituximab + standard chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Rituximab + standard chemotherapy
    description
    Rituximab is administered intravenously. The initial rate is 50 mg/hr for the first hour. If no toxicity is seen, the rate may be escalated gradually in 50 mg/hour increments at 30-minute intervals to a maximum of 300 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased gradually in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr.
    name
    Rituximab
    other Names
    1. Rituxan
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Rituximab + standard chemotherapy
    description
    3 g/m2/day in 500 cc D5W IV over 2 hrs. x 2 doses 24hrs. apart, Weeks 11, 14
    name
    Cytarabine
    other Names
    1. Cytosar-U
    2. Ara-C
    3. Arabinosylcytosine
    type
    DRUG
  3. arm Group Labels
    1. Rituximab + standard chemotherapy
    description
    16mg (week 1) PO daily Weeks 1, 2, 3, 4, 5, 6 Taper by 4 mg/wk, weeks 2, 3, by 2 mg/wk week 4, 5, 6
    name
    Dexamethasone
    other Names
    1. Decadron
    2. Dexasone
    3. Diodex
    4. Hexadrol
    5. Maxidex
    6. dexamethasone sodium phosphate
    7. dexamethasone acetate
    type
    DRUG
  4. arm Group Labels
    1. Rituximab + standard chemotherapy
    description
    25 mg PO/IV every 6 hrs. x 12 doses, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally 10 mg PO every 12 hrs. x 8 doses, Weeks 2, 4, 6, 8, 10
    name
    Leucovorin
    other Names
    1. leucovorin calcium
    type
    DRUG
  5. arm Group Labels
    1. Rituximab + standard chemotherapy
    description
    3.5 g/m2In 500 cc D5W + 25 mEq NaHCO3 IV over 2 hours, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally: 12 mg Intrathecally, in preservative-free sterile .9NS Weeks 2, 4, 6, 8, 10 Via Ommaya or lumbar puncture
    name
    Methotrexate
    other Names
    1. Otrexup
    2. Rasuvo
    3. Rheumatrex
    4. Trexall
    5. Amethopterin
    6. Methotrexate Sodium
    7. MTX
    type
    DRUG
  6. arm Group Labels
    1. Rituximab + standard chemotherapy
    description
    100 mg/m2 PO daily x 7 days Weeks 1, 5, 9
    name
    Procarbazine
    other Names
    1. Matulane
    2. Procarbazine hydrochloride
    type
    DRUG
  7. arm Group Labels
    1. Rituximab + standard chemotherapy
    description
    1.4 mg/m2 IV push, Weeks 1, 3, 5, 7, 9 2m2 (2.8 mg) dose cap
    name
    Vincristine
    other Names
    1. Vincristine Sulfate
    2. Oncovin
    3. Vincasar
    4. LCR
    5. VCR
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
26
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites. Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks.
    measure
    Complete Response Rate - Locally Reviewed
    time Frame
    For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).
Full study description
brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with primary central nervous system (CNS) lymphoma.
detailed Description
OBJECTIVES: Primary * Determine the complete response rate. Secondary * Determine the progression-free survival of these patients. * Determine the proportion of progression-free and overall survival in these patients. * Determine rituximab cerebrospinal fluid pharmacokinetics (only in patients requiring intrathecal chemotherapy). OUTLINE: This is a multicenter study. Patients receive rituximab IV 3 times weekly in weeks 1-4; high-dose methotrexate IV over 2 hours in weeks 1, 3, 5, and 9; oral or IV leucovorin calcium every 6 hours for 12 doses beginning 24 hours after the start of methotrexate in weeks 1, 3, 5, and 9; vincristine IV in weeks 1, 3, 5, 7, and 9; oral procarbazine hydrochloride daily on days 1-7 in weeks 1, 5, and 9; oral dexamethasone daily in weeks 1-6; and cytarabine IV over 2 hours twice weekly in weeks 11 and 14. Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of methotrexate in weeks 2, 4, 6, 8, and 10. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
Source references
references
  1. citation
    Swinnen LJ, O'Neill A, Imus PH, Gujar S, Schiff D, Kleinberg LR, Advani RH, Dunbar EM, Moore D, Grossman SA. Phase II study of rituximab given in conjunction with standard chemotherapy in primary central nervous system lymphoma (PCNSL): a trial of the ECOG-ACRIN cancer research group (E1F05). Oncotarget. 2017 Nov 6;9(1):766-773. doi: 10.18632/oncotarget.22332. eCollection 2018 Jan 2.
    pmid
    29416652
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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        start
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      offset unit
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      query cond
      Primary Central Nervous System Lymphoma
      query disease state id
      ds-primary-central-nervous-system-lymphoma
      source file
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    Preserved source evidence · Not medical advice