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Intensive Chemotherapy And Immunotherapy In Patients With Newly Diagnosed Primary CNS Lymphoma


Phase 2
N/A
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

Intensive Chemotherapy And Immunotherapy In Patients With Newly Diagnosed Primary CNS Lymphoma


OBJECTIVES:

Primary

- Determine the complete response rate after remission induction therapy with the
combination of high-dose methotrexate (HDMTX), temozolomide, and rituximab at 4 months.

Secondary

- Determine the safety and feasibility of consolidation therapy comprising cytarabine and
etoposide administered after induction therapy in these patients.

- Determine the percentage of patients who achieve durable (complete and partial)
remission when treated with this regimen.

- Determine relapse-free survival after complete response in patients treated with this
regimen.

- Correlate molecular markers with outcome in patients treated with this regimen.

- Determine the effects of this regimen on neurological function in these patients.

OUTLINE: This is a multicenter study.

- Induction Chemotherapy: All induction therapy courses repeat every 28 days.

- Courses 1-3: Patients receive high-dose methotrexate IV over 4 hours on days 1 and
15, leucovorin calcium IV or orally every 6 hours beginning on days 2 and 16 and
continuing until blood levels of methotrexate are in a safe range, and oral
temozolomide on days 7-11. Patients also receive rituximab* IV on days 3, 10, 17,
and 24 of course 1 and days 3 and 10 of course 2 (total of 6 doses).

NOTE: *Patients diagnosed with T-cell primary CNS lymphoma do not receive rituximab.

- Course 4: Patients receive oral temozolomide on days 7-11, high-dose methotrexate IV
over 4 hours on day 15, and leucovorin calcium IV or orally every 6 hours beginning on
day 16 and continuing until blood levels of methotrexate are in a safe range. Patients
achieving a complete response or a complete response unconfirmed proceed to
consolidation therapy.

- Consolidation therapy I (course 5): Beginning 4 weeks after the start of course 4,
patients receive high-dose methotrexate IV over 4 hours on day 1, leucovorin
calcium IV or orally every 6 hours beginning on day 2 and continuing until blood
levels of methotrexate are in a safe range, and oral temozolomide on days 7-11.

- Consolidation therapy II (course 6): Beginning 3-5 weeks after the start of course
5, patients receive cytarabine IV over 2 hours twice daily and etoposide IV over
12 hours twice daily on days 1-4 and filgrastim (G-CSF) or sargramostim (GM-CSF)
subcutaneously beginning on day 14 and continuing until blood counts recover.

Treatment continues in the absence of disease progression.

After completion of study treatment, patients are followed periodically for 3 years.

PROJECTED ACCRUAL: A total of 27-45 patients will be accrued for this study within 2-3
years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed primary CNS lymphoma confirmed by 1 of the
following methods:

- Brain biopsy or resection

- Cerebrospinal fluid (CSF) cytology

- Positive CSF cytology with or without measurable intracranial disease

- No evidence of systemic non-Hodgkin's lymphoma

- CT scan or MRI of the chest, abdomen, and pelvis AND bilateral bone marrow
biopsy or unilateral biopsy with a 2cm core biopsy specimen that is negative for
extracerebral source of lymphoma

- Measurable contrast-enhancing disease by MRI of the brain and spine (plus gadolinium)
unless CSF cytology positive

- No evidence of pleural effusions or ascites

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

- ALT and AST ≤ 2 times upper limit of normal

- Bilirubin ≤ 2 mg/dL

Renal

- Creatinine clearance ≥ 50 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after study participation

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Concurrent steroids for the management of symptoms related to lymphoma allowed

Radiotherapy

- No concurrent palliative radiotherapy

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response after remission induction

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

James L. Rubenstein, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Federal Government

Study ID:

CDR0000398106

NCT ID:

NCT00098774

Start Date:

October 2004

Completion Date:

November 2012

Related Keywords:

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

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Stony Brook University Cancer CenterStony Brook, New York  11794-8174
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Rhode Island Hospital Comprehensive Cancer CenterProvidence, Rhode Island  02903
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115
Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240
Fort Wayne Medical Oncology and HematologyFort Wayne, Indiana  46815
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Mountainview MedicalBerlin, Vermont  05602
Danville Regional Medical CenterDanville, Virginia  24541
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Menorah Medical CenterOverland Park, Kansas  66209
Saint Luke's Hospital - SouthOverland Park, Kansas  66213
Shawnee Mission Medical CenterShawnee Mission, Kansas  66204
Union Hospital Cancer Program at Union HospitalElkton MD, Maryland  21921
Truman Medical Center - Hospital HillKansas City, Missouri  64108
St. Joseph Medical CenterKansas City, Missouri  64114
North Kansas City HospitalKansas City, Missouri  64116
Saint Luke's Cancer Institute at Saint Luke's HospitalKansas City, Missouri  64111
Research Medical CenterKansas City, Missouri  64132
Saint Luke's East - Lee's SummitLee's Summit, Missouri  64086
Liberty HospitalLiberty, Missouri  64068
Heartland Regional Medical CenterSaint Joseph, Missouri  64506
Miriam HospitalProvidence, Rhode Island  02906
Parvin Radiation OncologyKansas City, Missouri  64116