Combination Chemotherapy, Monoclonal Antibody, and Radiation Therapy in Treating Patients With Primary Central Nervous System Lymphoma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Radiation Therapy Oncology Group
Study ID
NCT00068250
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Brain and Central Nervous System Tumors
  • Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • rituximab — DRUG
    375 mg/m2, intravenously three days prior to the first cycle of methotrexate
  • methotrexate — DRUG
    Five cycles of methotrexate (MTX) at 3.5 gm/m2 administered every two weeks on weeks 1, 3, 5, 7, and 9 via intravenous infusion over four hours once per cycle. Calcium leucovorin 25 mg orally or intravenously every six hours initiated exactly 24 hours following the start of the MTX infusion. Methotrexate levels to be monitored daily, and calcium leucovorin discontinued when the MTX level is less than 10 micromolar.
  • temozolomide 100 mg/m^2 — DRUG
    Temozolomide 100 mg/m\^2 by mouth per day for five days on weeks 4 and 8.
  • temozolomide 150 mg/m^2 — DRUG
    Temozolomide 150 mg/m\^2 by mouth per day for five days on weeks 4 and 8.
  • temozolomide 200 mg/m^2 — DRUG
    Temozolomide 200 mg/m\^2 per day by mouth for five days on weeks 4 and 8.
  • radiation therapy — RADIATION
    Whole brain irradiation (WBRT) during weeks 11, 12, and 13, five days per week (excluding weekends). A daily dose of 2.4 Gy delivered in two fractions of 1.2 Gy each with a minimum inter-fraction interval of 6 hours, with a total dose to brain and meninges of 36 Gy.
  • post-radiation therapy temozolomide — DRUG
    Temozolomide (TMZ) 200 mg/m\^2 by mouth per day for 5 days on weeks 14, 18, 22, 26, 30, 34, 38, 42, 46, and 50 for a total of 10 cycles.

Study Details

RATIONALE: Drugs used in chemotherapy such as methotrexate and temozolomide use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining methotrexate, temozolomide, and rituximab with radiation therapy may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of temozolomide when given together with methotrexate and rituximab followed by radiation therapy and to see how well they work in treating patients with primary central nervous system lymphoma.

Key Dates

Start date
Jul 31, 2003
Status verified
Feb 2018
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I: Temozolomide 100 mg
    Rituximab, methotrexate, temozolomide 100 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2.
  • Experimental: Phase I: Temozolomide 150 mg
    Rituximab, methotrexate, temozolomide 150 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2.
  • Experimental: Phase I: Temozolomide 200 mg
    Rituximab, methotrexate, temozolomide 200 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2.
  • Experimental: Phase II: Temozolomide 100 mg
    Rituximab, methotrexate, temozolomide 100 mg/m\^2, followed by radiation therapy, then post-radiation therapy temozolomide 200 mg/m\^2.

Primary Outcome Measure

Number of Phase I Participants Experiencing Toxicity [ Time Frame: From start of treatment to 10 weeks if radiation therapy received, to 15 weeks if not. ]

Locations (26)

FacilityCityStateZIPSite coordinators
Baptist Cancer Institute - JacksonvilleJacksonvilleFlorida32207-
Baptist Medical Center SouthJacksonvilleFlorida32258-
Integrated Community Oncology Network at Southside Cancer CenterJacksonvilleFlorida32207-
Integrated Community Oncology NetworkJacksonville BeachFlorida32250-
Integrated Community Oncology Network - Orange ParkOrange ParkFlorida32073-
Florida Cancer Center - PalatkaPalatkaFlorida32177-
Flagler Cancer CenterSaint AugustineFlorida32086-
Borgess Medical CenterKalamazooMichigan49001-
Bronson Methodist HospitalKalamazooMichigan49007-
West Michigan Cancer CenterKalamazooMichigan49007-3731-
CCOP - Kansas CityKansas CityMissouri64131-
Siteman Cancer Center at Barnes-Jewish Hospital - Saint LouisSt LouisMissouri63110-
CCOP - Nevada Cancer Research FoundationLas VegasNevada89106-
John F. Kennedy Medical CenterEdisonNew Jersey08818-
Cleveland Clinic Taussig Cancer CenterClevelandOhio44195-
Providence Milwaukie HospitalMilwaukieOregon97222-
CCOP - Columbia River Oncology ProgramPortlandOregon97225-
Providence Cancer Center at Providence Portland Medical CenterPortlandOregon97213-2967-
Providence St. Vincent Medical CenterPortlandOregon97225-
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphiaPennsylvania19107-5541-
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425-
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurrayUtah84157-
Utah Valley Regional Medical Center - ProvoProvoUtah84604-
Southwest Washington Medical Center Cancer CenterVancouverWashington98668-
Community Memorial Hospital Cancer Care CenterMenomonee FallsWisconsin53051-
Medical College of Wisconsin Cancer CenterMilwaukeeWisconsin53226-

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Baptist Cancer Institute - Jacksonville· Jacksonville, FLBaptist Medical Center South· Jacksonville, FLIntegrated Community Oncology Network at Southside Cancer Center· Jacksonville, FLIntegrated Community Oncology Network· Jacksonville Beach, FLIntegrated Community Oncology Network - Orange Park· Orange Park, FLFlorida Cancer Center - Palatka· Palatka, FL

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