Non Hodgkin Lymphoma Clinical Trial

Rituximab, Temozolomide, and Methylprednisolone in Treating Patients With Recurrent Primary CNS Non-Hodgkin’s Lymphoma

Summary

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as temozolomide and methylprednisolone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Rituximab may help chemotherapy kill more cancer cells by making cancer cells more sensitive to the drugs. Giving rituximab together with temozolomide and methylprednisolone may be an effective treatment for primary CNS non-Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving rituximab together with temozolomide and methylprednisolone works in treating patients with recurrent primary CNS non-Hodgkin's lymphoma.

View Full Description

Full Description

OBJECTIVES:

Primary

Determine the response rate in patients with recurrent primary CNS non-Hodgkin's lymphoma treated with rituximab, temozolomide, and methylprednisolone.

Secondary

Determine the overall and 6-month progression-free survival of patients treated with this regimen.

OUTLINE: Induction therapy: Patients receive rituximab IV over 30-60 minutes on days 1, 8, 15, and 22 and oral temozolomide daily on days 1-7 and 15-21. After day 28, patients with stable disease or better proceed to consolidation therapy.

Consolidation therapy: Patients receive oral temozolomide daily on days 1-5. Treatment repeats every 28 days for up to 6 courses. Patients achieving a complete remission proceed to maintenance therapy.

Maintenance therapy: Patients receive methylprednisolone IV over 2 hours on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within approximately 13.3 months.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary CNS non-Hodgkin's lymphoma by brain biopsy, positive cerebrospinal fluid cytology, or vitrectomy

Recurrent disease

Measurable disease, define as bi-dimensionally measurable lesions with clearly defined margins by brain MRI or CT scan

Radiographical evidence of tumor progression by MRI or CT scan
Steroid therapy must be stable for 5 days prior to scan

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Karnofsky 60-100%

Life expectancy

More than 8 weeks

Hematopoietic

WBC ≥ 3,000/mm^3
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Hemoglobin ≥ 10 g/dL (transfusion allowed)

Hepatic

SGOT < 2 times upper limit of normal (ULN)
Bilirubin < 2 times ULN
No active or latent hepatitis B infection

Renal

Creatinine < 1.5 mg/dL OR
Creatinine clearance ≥ 60 mL/min

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
No uncontrolled significant medical illness that would preclude study treatment
No active infection
No active HIV infection
No concurrent disease that would dangerously alter drug metabolism or obscure toxicity

PRIOR CONCURRENT THERAPY:

Biologic therapy

At least 7 days since prior interferon or thalidomide
No concurrent prophylactic filgrastim (G-CSF)
No concurrent immunotherapy

Chemotherapy

No prior temozolomide
At least 14 days since prior methotrexate
At least 21 days since prior procarbazine
At least 42 days since prior nitrosoureas
No other concurrent chemotherapy

Endocrine therapy

See Disease Characteristics
At least 7 days since prior tamoxifen
No concurrent hormonal therapy

Radiotherapy

No concurrent radiotherapy

Surgery

Not specified

Other

Recovered from all prior therapy
At least 28 days since prior investigational agents
At least 28 days since other prior cytotoxic therapy
At least 7 days since other prior non-cytotoxic agents (e.g., tretinoin) (radiosenitizers allowed)
No other concurrent investigational drugs

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00248534

Recruitment Status:

Terminated

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15232, United States
M. D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78284, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00248534

Recruitment Status:

Terminated

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider