Know Cancer

or
forgot password

A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Study of Rituximab and Temozolomide in Recurrent Primary CNS Lymphoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate assessed by MRI every 2 months

Safety Issue:

No

Principal Investigator

Lauren E. Abrey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000445289

NCT ID:

NCT00248534

Start Date:

September 2005

Completion Date:

Related Keywords:

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

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
UPMC Cancer CentersPittsburgh, Pennsylvania  15232