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Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma


OBJECTIVES:

Primary

- Determine the complete response rate.

Secondary

- Determine the progression-free survival of these patients.

- Determine the proportion of progression-free and overall survival in these patients.

- Determine rituximab cerebrospinal fluid pharmacokinetics (only in patients requiring
intrathecal chemotherapy).

OUTLINE: This is a multicenter study.

Patients receive rituximab IV 3 times weekly in weeks 1-4; high-dose methotrexate IV over 2
hours in weeks 1, 3, 5, and 9; oral or IV leucovorin calcium every 6 hours for 12 doses
beginning 24 hours after the start of methotrexate in weeks 1, 3, 5, and 9; vincristine IV
in weeks 1, 3, 5, 7, and 9; oral procarbazine hydrochloride daily on days 1-7 in weeks 1, 5,
and 9; oral dexamethasone daily in weeks 1-6; and cytarabine IV over 2 hours twice weekly in
weeks 11 and 14.

Patients with positive cerebrospinal fluid also receive methotrexate intrathecally and oral
leucovorin calcium every 12 hours for 8 doses beginning 24 hours after the start of
methotrexate in weeks 2, 4, 6, 8, and 10.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed non-Hodgkin's lymphoma by brain biopsy

- Patients with inconclusive biopsy or patients who are not candidates for biopsy must
have typical CT scan or MRI of the brain AND meet ≥ 1 of the following criteria:

- Positive cerebrospinal fluid cytology for lymphoma OR a monoclonal lymphoid
population as defined by cell surface markers or immunoglobulin gene
rearrangement studies

- Biopsy-proven involvement of the vitreous or uvea if cells are apparent in the
posterior chamber or vitreous by ophthalmological examination

- Bideminsionally measurable disease, defined as contrast-enhancing tumor ≥ 1 cm by
pretreatment MRI/CT scan

- Meningeal or vitreous involvement constitutes evaluable but not measurable
disease

- If an excisional, rather than a needle biopsy was done, measurable disease must
be present on a postoperative scan

- PET-CT scan not allowed

- No systemic lymphoma (as determined by pre-registration CT scans and physical
examination)

PATIENT CHARACTERISTICS:

- ECOG performance status 0-3

- Absolute granulocyte count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Bilirubin ≤ upper limit of normal (ULN)

- SGOT ≤ 2.0 times ULN

- Creatinine clearance ≥ 50 mL/min

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No HIV-1 positivity

- No other malignancy within the past 5 years except basal cell skin cancer or any
carcinoma in situ

- No pre-existing immunodeficiency

- No hepatitis B surface antigen positivity

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy for primary central nervous system lymphoma

- No prior organ or bone marrow transplantation

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate at the end of study treatment

Safety Issue:

No

Principal Investigator

Lode J. Swinnen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000475776

NCT ID:

NCT00335140

Start Date:

December 2006

Completion Date:

Related Keywords:

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

Name

Location

Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Aultman Cancer Center at Aultman HospitalCanton, Ohio  44710-1799
MetroHealth Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44109
Geisinger Medical Group - Scenery ParkState College, Pennsylvania  16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical CenterWilkes-Barre, Pennsylvania  18711
Sanford Cancer Center at Sanford USD Medical CenterSioux Falls, South Dakota  57117-5039
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Wesley Medical CenterWichita, Kansas  67214
University of Florida Shands Cancer CenterGainesville, Florida  32610-0232
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Southwest Medical CenterLiberal, Kansas  67901
Geisinger Cancer Institute at Geisinger HealthDanville, Pennsylvania  17822-0001
West Virginia University Health Sciences Center - CharlestonCharleston, West Virginia  25302
Gundersen Lutheran Center for Cancer and BloodLa Crosse, Wisconsin  54601
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Stanford Cancer CenterStanford, California  94305-5824
McFarland Clinic, PCAmes, Iowa  50010
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Barberton Citizens HospitalBarberton, Ohio  44203
Geisinger Hazleton Cancer CenterHazleton, Pennsylvania  18201
John H. Stroger, Jr. Hospital of Cook CountyChicago, Illinois  60612-9985