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NCT00074165 · REGISTRY CONDITION SEARCH

Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

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
2023-07-06

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent 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

Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.

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outcome · POSTED

Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response

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outcome · POSTED

Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression

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outcome · POSTED

Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months

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outcome · POSTED

Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment

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outcome · POSTED

Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment

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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: * Signed informed consent form in accordance with institutional guidelines * Histologically or cytologically confirmed primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis * CD20 positive disease * Progressive or relapsed disease during or after completion of prior methotrexate-based chemotherapy * Aged 18 months to 75 years * Performance status ECOG 0-3 OR Karnofsky 30-100% * Hematocrit at least 25% (transfusion or epoetin alfa allowed) * Absolute granulocyte count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 OR at least lower limit of normal * Bilirubin no greater than 2.0 times upper limit of normal * Creatinine less than 1.8 mg/dL * Calculated Creatinine clearance (CrCl) at least 50 mL/min * Adequate cardiac function to tolerate general anesthesia * Adequate pulmonary function to tolerate general anesthesia * Available for follow-up for 1 year post therapy * Fertile patients must use effective contraception for a minimum of 2 months before and during study participation EXCLUSION CRITERIA: * Radiographic signs of intra-cranial herniation and/or spinal block * HIV positive * Systemic lymphoma * Positive serum HCG, pregnant or lactating * Allergy to study agents * Hepatitis B or hepatitis C positive
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Months
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: Rituxan
    2. Drug: Cyclophosphamide
    3. Drug: Etoposide
    4. Drug: Etoposide phosphate
    5. Drug: Carboplatin
    6. Drug: Sodium thiosulfate
    7. Drug: Neupogen
    8. Drug: Neulasta
    9. Drug: Cytarabine
    label
    All subjects
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. All subjects
    description
    Total dose: 375mg/m2 infused IV; Every 4 weeks for up to one year.
    name
    Rituxan
    other Names
    1. Rituximab
    type
    DRUG
  2. arm Group Labels
    1. All subjects
    description
    Dose 330mg/m2 x 2 days infused IV; Every 4 weeks for up to 1 year
    name
    Cyclophosphamide
    type
    DRUG
  3. arm Group Labels
    1. All subjects
    description
    Dose 200mg/m2 x 2 days infused IV; Every 4 weeks for up to one year. Etoposide phosphate may be given instead.
    name
    Etoposide
    type
    DRUG
  4. arm Group Labels
    1. All subjects
    description
    Dose 200mg/m2 infused IV x 2 days; Every 4 weeks for up to one year. Etoposide may be given instead.
    name
    Etoposide phosphate
    type
    DRUG
  5. arm Group Labels
    1. All subjects
    description
    Dose: 200mg/m2 x 2 days infused IA with BBBD; Every 4 weeks for up to one year.
    name
    Carboplatin
    type
    DRUG
  6. arm Group Labels
    1. All subjects
    description
    Dose: 4 hrs post carboplatin = 20gm/m2; Dose: 8 hrs post carboplatin = 16gm/m2 Infused IV x 2 days
    name
    Sodium thiosulfate
    other Names
    1. STS
    type
    DRUG
  7. arm Group Labels
    1. All subjects
    description
    48 hours after chemotherapy, QD x 7-10 days until WBC greater than 5000. Neulasta (Pegfilgrastim) may be given instead.
    name
    Neupogen
    other Names
    1. G-CSF
    2. filgrastim
    type
    DRUG
  8. arm Group Labels
    1. All subjects
    description
    Dose: 6mg, 24-72 hours after chemotherapy. Neupogen may be given instead.
    name
    Neulasta
    other Names
    1. Pegfilgrastim
    type
    DRUG
  9. arm Group Labels
    1. All subjects
    description
    Dose: 40mg on Day 14 following chemotherapy
    name
    Cytarabine
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
17
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.
    measure
    Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years.
    time Frame
    2 years
secondary Outcomes
  1. description
    Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.
    measure
    Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response
    time Frame
    5 years
  2. measure
    Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression
    time Frame
    5 years
  3. measure
    Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months
    time Frame
    5 years
  4. measure
    Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment
    time Frame
    2 years
  5. measure
    Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment
    time Frame
    2 years
Full study description
brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain tumor. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.
detailed Description
OBJECTIVES: Primary * Determine the efficacy of rituximab, carboplatin, cyclophosphamide, etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate, in terms of complete response rate, in patients with refractory or recurrent primary CNS lymphoma. Secondary * Determine the overall survival and 2-year progression-free survival of patients treated with this regimen. * Determine the quality of life and cognitive function of patients treated with this regimen. * Determine the neurotoxicity of this regimen in these patients. * Determine the percentage of patients with ototoxicity over time after treatment with this regimen. * Determine the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in these patients. OUTLINE: This is a multicenter study. Patients receive rituximab IV on day 1. On days 2 and 3, patients receive carboplatin intra-arterially over 10 minutes, cyclophosphamide IV over 10 minutes, and etoposide or etoposide phosphate IV over 10 minutes in conjunction with blood-brain barrier disruption. Patients also receive high-dose sodium thiosulfate IV over 15 minutes administered 4 and 8 hours after carboplatin on days 2 and 3 and intraventricular or intrathecal cytarabine on day 14. Beginning 48 hours after the last dose of chemotherapy, patients receive filgrastim (G-CSF)\* subcutaneously (SC) daily for 7-10 days or until blood counts recover. Treatment repeats every 4 weeks for up to 12 courses. NOTE: \* Alternatively, patients may receive a single dose of pegfilgrastim SC, administered 48 hours after the completion of chemotherapy Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam; once weekly for 1 month; and then monthly for 1 year. Quality of life is assessed at baseline, every 3 months during treatment, within 30 days of final treatment, then every 6 months for 1 year, and then annually thereafter. Patients are followed monthly for 3 months, every 2 months for 8 months, every 3 months for 1 year, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 11-25 patients will be accrued for this study within 7-10 years.
Source references
Source notices and limitations
    Discovery and provenance
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      id
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      occurrences
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        exact text
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        start
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      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 string basis
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      source string sha256
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    Preserved source evidence · Not medical advice