Clinical trial NCT00072449: Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma
Official title: A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
Keywords: primary central nervous system non-Hodgkin lymphoma
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-11-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have refractory or relapsed primary CNS lymphoma.

Detailed description: OBJECTIVES:

Primary

* Determine the radiographic response proportion in patients with refractory or recurrent primary CNS lymphoma treated with rituximab.

Secondary

* Determine the progression-free and overall survival of patients treated with this drug.
* Determine the toxicity profile of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on days 1, 8, 15, and 22. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses of rituximab off study at the discretion of the treating physician.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 5-9 months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed primary CNS lymphoma based on 1 of the following:

  * Histologically confirmed non-Hodgkin's B-cell lymphoma by brain biopsy or resection
  * Positive cerebrospinal fluid (CSF) cytology or immunohistochemical diagnosis of CSF monoclonality with or without measurable intracranial disease
  * Histologically confirmed vitreal lymphoma with measurable intracranial tumor
* CD20 positive by brain biopsy
* Measurable (greater than 1 cm in diameter) tumor by CT scan or MRI
* Progressed during first-line chemotherapy and/or radiotherapy OR relapsed after initial successful treatment
* No systemic lymphoma by CT scan of the chest, abdomen, and pelvis with contrast
* No leptomeningeal lymphoma by lumbar puncture for CNS cytology/flow cytometry
* No ocular lymphoma by slit lamp examination

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL

Hepatic

* Bilirubin less than 1.5 mg/dL
* Transaminases less than 4 times upper limit of normal

Renal

* Creatinine less than 1.5 mg/dL

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 1 year after study participation
* HIV negative
* Mini mental status examination score at least 15
* No concurrent serious infection
* No other medical illness that would preclude study treatment
* No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ

PRIOR CONCURRENT THERAPY:

Biologic therapy

* More than 90 days since prior biologic therapy
* No prior rituximab
* No concurrent prophylactic growth factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\])

Chemotherapy

* See Disease Characteristics
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* At least 3 months since prior radiotherapy

Surgery

* Not specified

Other

* Recovered from prior therapy
* More than 90 days since prior investigational drugs
* More than 90 days since prior use of a therapeutic device

Primary outcomes:
measure: Radiographic Response
timeFrame: 1 month, 2 months and then q3months
Secondary outcomes:
measure: Progression-free Survival
timeFrame: pt had MRI q3months
measure: Overall Survival
timeFrame: 47 months
measure: Toxicity
timeFrame: 8 weeks - 2 cycles
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
state: Alabama
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Josephine Ford Cancer Center at Henry Ford Hospital
state: Michigan
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: Tracy Batchelor, MD, MPH
role: STUDY_CHAIR
References:
citation: Batchelor TT, Grossman SA, Mikkelsen T, Ye X, Desideri S, Lesser GJ. Rituximab monotherapy for patients with recurrent primary CNS lymphoma. Neurology. 2011 Mar 8;76(10):929-30. doi: 10.1212/WNL.0b013e31820f2d94. No abstract available.