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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


Phase 2
18 Months
75 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Drug/Agent Toxicity by Tissue/Organ, Lymphoma, Thrombocytopenia

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Edward A. Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

OHSU-641

NCT ID:

NCT00074165

Start Date:

January 2003

Completion Date:

December 2010

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Drug/Agent Toxicity by Tissue/Organ
  • Lymphoma
  • Thrombocytopenia
  • drug/agent toxicity by tissue/organ
  • thrombocytopenia
  • intraocular lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • primary central nervous system Hodgkin lymphoma
  • Lymphoma
  • Nervous System Neoplasms
  • Thrombocytopenia
  • Central Nervous System Neoplasms

Name

Location
Knight Cancer Institute at Oregon Health and Science University Portland, Oregon  97239-3098
Good Samaritan Hospital Cancer Treatment Center, Hatton Institute Cincinnati, Ohio  45220