Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00072449
• Other study ID #: NABTT-2201 CDR0000339737
• Secondary ID: U01CA062475NABTT
• Status: Terminated
• Phase: Phase 2
• First received: November 4, 2003
• Last updated: June 14, 2013
• Start date: May 2004
• Est. completion date: June 2010

Study information

• Verified date: June 2013
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• rituximab

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida	Tampa	Florida
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiographic Response	it at any time point patient progresses no more scans are required, patient is off study	1 month, 2 months and then q3months	No
Secondary	Progression-free Survival	pt had MRI every 3 months	pt had MRI q3months	No
Secondary	Overall Survival	survival was evaluated q 2months	47 months	No
Secondary	Toxicity	patients only received drug for 8 weeks	8 weeks - 2 cycles	Yes