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Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

This study has been terminated.
(slow accrual)
Sponsor:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00335140
First received: June 7, 2006
Last updated: May 23, 2017
Last verified: May 2017
June 7, 2006
May 23, 2017
December 2006
July 2015   (Final data collection date for primary outcome measure)
Complete Response Rate - Locally Reviewed [ Time Frame: For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17). ]

Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites.

Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks.

Not Provided
Complete list of historical versions of study NCT00335140 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma
Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy works in treating patients with 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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lymphoma
  • Biological: Rituximab
    Rituximab is administered intravenously. The initial rate is 50 mg/hr for the first hour. If no toxicity is seen, the rate may be escalated gradually in 50 mg/hour increments at 30-minute intervals to a maximum of 300 mg/hr. If the first dose is well tolerated, the initial rate for subsequent dose is 100 mg/hr, increased gradually in 100 mg/hr increments at 30-minute intervals, not to exceed 400 mg/hr.
    Other Name: Rituxan
  • Drug: Cytarabine
    3 g/m2/day in 500 cc D5W IV over 2 hrs. x 2 doses 24hrs. apart, Weeks 11, 14
    Other Names:
    • Cytosar-U
    • Ara-C
    • Arabinosylcytosine
  • Drug: Dexamethasone
    16mg (week 1) PO daily Weeks 1, 2, 3, 4, 5, 6 Taper by 4 mg/wk, weeks 2, 3, by 2 mg/wk week 4, 5, 6
    Other Names:
    • Decadron
    • Dexasone
    • Diodex
    • Hexadrol
    • Maxidex
    • dexamethasone sodium phosphate
    • dexamethasone acetate
  • Drug: Leucovorin
    25 mg PO/IV every 6 hrs. x 12 doses, Weeks 1, 3, 5, 7, 9 For patients with meningeal involvement additionally 10 mg PO every 12 hrs. x 8 doses, Weeks 2, 4, 6, 8, 10
    Other Name: leucovorin calcium
  • Drug: Methotrexate

    3.5 g/m2In 500 cc D5W + 25 mEq NaHCO3 IV over 2 hours, Weeks 1, 3, 5, 7, 9

    For patients with meningeal involvement additionally:

    12 mg Intrathecally, in preservative-free sterile .9NS Weeks 2, 4, 6, 8, 10 Via Ommaya or lumbar puncture

    Other Names:
    • Otrexup
    • Rasuvo
    • Rheumatrex
    • Trexall
    • Amethopterin
    • Methotrexate Sodium
    • MTX
  • Drug: Procarbazine
    100 mg/m2 PO daily x 7 days Weeks 1, 5, 9
    Other Names:
    • Matulane
    • Procarbazine hydrochloride
  • Drug: Vincristine
    1.4 mg/m2 IV push, Weeks 1, 3, 5, 7, 9 2m2 (2.8 mg) dose cap
    Other Names:
    • Vincristine Sulfate
    • Oncovin
    • Vincasar
    • LCR
    • VCR
Experimental: Rituximab + standard chemotherapy
Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
Interventions:
  • Biological: Rituximab
  • Drug: Cytarabine
  • Drug: Dexamethasone
  • Drug: Leucovorin
  • Drug: Methotrexate
  • Drug: Procarbazine
  • Drug: Vincristine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
26
July 2015
July 2015   (Final data collection date for primary outcome measure)

Inclusion criteria:

  • 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 (not a PET-CT scan)
  • 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
  • Negative pregnancy test
  • Fertile patients must use effective contraception

Exclusion criteria:

  • Pregnant or nursing
  • HIV-1 positivity
  • Other malignancy within the past 5 years except basal cell skin cancer or any carcinoma in situ
  • Pre-existing immunodeficiency
  • Hepatitis B surface antigen positivity
  • Systemic lymphoma (as determined by pre-registration CT scans and physical examination)
  • Prior chemotherapy or radiotherapy for primary central nervous system lymphoma
  • Prior organ or bone marrow transplantation
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00335140
CDR0000475776
ECOG-E1F05 ( Other Identifier: ECOG-ACRIN )
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
Not Provided
Study Chair: Lode J. Swinnen, MD Sidney Kimmel Comprehensive Cancer Center
Study Chair: Deborah T. Blumenthal, MD University of Utah
Eastern Cooperative Oncology Group
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP