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A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study Of Anti-CD20 Monoclonal Antibody (Rituximab) Therapy For Patients With Refractory Or Relapsed Primary CNS Lymphoma (PCNSL)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiographic response

Safety Issue:

No

Principal Investigator

Tracy Batchelor, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

NABTT-2201 CDR0000339737

NCT ID:

NCT00072449

Start Date:

May 2004

Completion Date:

June 2010

Related Keywords:

  • Lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • Lymphoma

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Massachusetts General HospitalBoston, Massachusetts  02114-2617
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294