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Brain and Central Nervous System TumorsPhase 2NCT00074165

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

A Phase 2 study testing Rituxan, Cyclophosphamide and Etoposide in people with Brain and Central Nervous System Tumors and Drug/Agent Toxicity by Tissue/Organ, run by OHSU Knight Cancer Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 months to 75 years
What is being tested?
Rituxan, Cyclophosphamide and Etoposide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
2 sitesUnited States
Study dates
Jan 2003to Dec 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 months to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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%
Show all 16Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Good Samaritan Hospital Cancer Treatment Center, Hatton Institute

    Cincinnati, Ohio, 45220

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

Other trials in United States

About this study

Official title: A Phase II Trial Involving Patients With Recurrent PCNSL Treated With Carboplatin/BBBD, by Adding Rituxan (Rituximab), An Anti CD-20 Antibody, To The Treatment Regimen

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.

Read the 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.

Being tested
Rituxan, Cyclophosphamide, Etoposide, Etoposide phosphate, Carboplatin
Keywords
drug/agent toxicity by tissue/organ, thrombocytopenia, intraocular lymphoma, primary central nervous system non-Hodgkin lymphoma, primary central nervous system Hodgkin lymphoma
Medical subject headings
Central Nervous System Neoplasms, Drug-Related Side Effects and Adverse Reactions, Lymphoma, Thrombocytopenia, Intraocular Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituxanDrug

    Also called Rituximab

    Total dose: 375mg/m2 infused IV; Every 4 weeks for up to one year.

  • CyclophosphamideDrug

    Dose 330mg/m2 x 2 days infused IV; Every 4 weeks for up to 1 year

  • EtoposideDrug

    Dose 200mg/m2 x 2 days infused IV; Every 4 weeks for up to one year. Etoposide phosphate may be given instead.

  • Etoposide phosphateDrug

    Dose 200mg/m2 infused IV x 2 days; Every 4 weeks for up to one year. Etoposide may be given instead.

  • CarboplatinDrug

    Dose: 200mg/m2 x 2 days infused IA with BBBD; Every 4 weeks for up to one year.

  • Sodium thiosulfateDrug

    Also called STS

    Dose: 4 hrs post carboplatin = 20gm/m2;

    Dose: 8 hrs post carboplatin = 16gm/m2

    Infused IV x 2 days

  • NeupogenDrug

    Also called G-CSF, filgrastim

    48 hours after chemotherapy, QD x 7-10 days until WBC greater than 5000. Neulasta (Pegfilgrastim) may be given instead.

  • NeulastaDrug

    Also called Pegfilgrastim

    Dose: 6mg, 24-72 hours after chemotherapy. Neupogen may be given instead.

  • CytarabineDrug

    Dose: 40mg on Day 14 following chemotherapy

Study groups in NCT00074165
Study groupRoleWhat they receive
All subjectsExperimentalNot described
Receives: Drug: Rituxan; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Etoposide phosphate; Drug: Carboplatin; Drug: Sodium thiosulfate; Drug: Neupogen; Drug: Neulasta; Drug: Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Per RECIST criteria (v1.1) and assessed by magnetic resonance imaging (MRI): Complete response (CR), Disappearance of all target lesions.

    Measured: 2 years

Secondary outcomes (5)

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

    Overall survival is measured from entry onto study until death from any cause or until death or progression of disease, respectively.

    Measured: 5 years

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

    Measured: 5 years

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

    Measured: 5 years

  4. Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionJun 2010
  4. Study completionDec 2010

Why it stopped: Lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00074165
Sponsor's protocol ID
IRB00000641
Other IDs
5R01CA137488-15, ONC-02059-LX, 641, 7465, OHSU-641
Status last verified
Jun 2023
First submitted
10 Dec 2003
Last updated
6 Jul 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rituxan, Cyclophosphamide and Etoposide in people with Brain and Central Nervous System Tumors and Drug/Agent Toxicity by Tissue/Organ, run by OHSU Knight Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00074165.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023; AzTrials last refreshed its copy on 26 Oct 2026.

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