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History of Changes for Study: NCT00074165
Rituximab, Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Sodium Thiosulfate and Cytarabine in Treating Patients With Refractory or Recurrent Primary CNS Lymphoma
Latest version (submitted April 19, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 23, 2005 None (earliest Version on record)
2 September 8, 2005 Conditions, Study Status and Study Identification
3 February 6, 2006 Contacts/Locations and Study Status
4 February 16, 2006 Arms and Interventions and Study Status
5 April 5, 2006 Arms and Interventions and Study Status
6 May 23, 2006 Study Status
7 June 7, 2006 Study Status
8 June 8, 2006 Contacts/Locations and Study Status
9 September 6, 2006 Study Status
10 September 29, 2006 Contacts/Locations and Study Status
11 November 8, 2006 Study Design, Conditions, Outcome Measures, Study Status and Study Identification
12 December 4, 2006 Study Status
13 January 5, 2007 Conditions and Study Status
14 January 11, 2007 Conditions and Study Status
15 January 16, 2007 Study Status
16 February 20, 2007 Study Status
17 March 13, 2007 Study Status
18 July 3, 2007 Study Status
19 August 6, 2007 Contacts/Locations and Study Status
20 August 24, 2007 Contacts/Locations and Study Status
21 October 5, 2007 Study Status
22 October 13, 2007 Study Status
23 October 25, 2007 Arms and Interventions and Study Status
24 November 14, 2007 Contacts/Locations and Study Status
25 November 28, 2007 Contacts/Locations and Study Status
26 December 1, 2007 Contacts/Locations and Study Status
27 December 12, 2007 Contacts/Locations and Study Status
28 December 25, 2007 Study Status
29 January 5, 2008 Contacts/Locations, Sponsor/Collaborators and Study Status
30 January 8, 2008 Arms and Interventions and Study Status
31 April 8, 2008 Study Status
32 April 29, 2008 Study Status
33 May 8, 2008 Recruitment Status, Study Status and Contacts/Locations
34 May 23, 2008 Arms and Interventions and Study Status
35 June 17, 2008 Conditions and Study Status
36 June 21, 2008 Conditions and Study Status
37 July 23, 2008 Study Design and Study Status
38 October 8, 2008 Study Status
39 October 18, 2008 Conditions and Study Status
40 October 21, 2008 Study Status and Sponsor/Collaborators
41 December 13, 2008 Study Status
42 February 6, 2009 Arms and Interventions and Study Status
43 April 4, 2009 Sponsor/Collaborators and Study Status
44 May 9, 2009 Sponsor/Collaborators, Conditions and Study Status
45 June 13, 2009 Study Status
46 June 26, 2009 Recruitment Status, Contacts/Locations and Study Status
47 February 2, 2010 Sponsor/Collaborators, Contacts/Locations and Study Status
48 March 10, 2010 Conditions and Study Status
49 March 13, 2010 Conditions and Study Status
50 June 2, 2010 Study Identification, Arms and Interventions, Contacts/Locations, Study Status, Outcome Measures, Eligibility, Study Design, Study Description and Oversight
51 February 10, 2011 Recruitment Status, Study Status, Contacts/Locations and Study Design
52 October 10, 2011 Study Status, Outcome Measures, Sponsor/Collaborators and Results
53 November 21, 2011 Outcome Measures, Study Status, Adverse Events, Baseline Characteristics and Participant Flow
54 April 19, 2017 Sponsor/Collaborators, Outcome Measures, Study Status, Study Identification and Baseline Characteristics
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Study NCT00074165
Submitted Date:  June 23, 2005 (v1)

Open or close this module Study Identification
Unique Protocol ID: CDR0000343670
Brief Title: Rituximab, Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Sodium Thiosulfate and Cytarabine in Treating Patients With Refractory or Recurrent Primary CNS Lymphoma
Official Title: Phase II Study of Rituximab, Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate Administered in Conjunction With Osmotic Blood-Brain Barrier Disruption and High-Dose Sodium Thiosulfate and Cytarabine in Patients With Refractory or Recurrent Primary CNS Lymphoma
Secondary IDs: OHSU-7465
OHSU-ONC-02059-LX
NCT00074165
Open or close this module Study Status
Record Verification: December 2003
Overall Status: Recruiting
Study Start:
Primary Completion:
Study Completion:
First Submitted: December 10, 2003
First Submitted that
Met QC Criteria:
December 10, 2003
First Posted: December 11, 2003 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 23, 2005
Last Update Posted: June 24, 2005 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Oregon Health and Science University
Responsible Party:
Collaborators: National Cancer Institute (NCI)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
Brief Summary:

RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain. Chemoprotective drugs such as sodium thiosulfate may protect normal cells from the side effects of carboplatin-based chemotherapy. Combining rituximab with chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining rituximab with combination chemotherapy given with osmotic blood-brain barrier disruption plus sodium thiosulfate in treating patients who have refractory or recurrent primary CNS lymphoma.

Detailed Description:

OBJECTIVES:

Primary

  • Determine the efficacy of rituximab, carboplatin, cyclophosphamide, and etoposide or etoposide phosphate administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate and cytarabine, in terms of complete response rate, in patients with refractory or recurrent primary CNS lymphoma.

Secondary

  • Determine the overall survival and 2-year progression-free survival of patients treated with this regimen.
  • Determine the quality of life and cognitive function of patients treated with this regimen.
  • Determine the neurotoxicity of this regimen in these patients.
  • Determine the percentage of patients with ototoxicity over time after treatment with this regimen.
  • Determine the effect of delayed administration of sodium thiosulfate on granulocyte and erythrocyte counts in these patients.

OUTLINE: This is a multicenter study.

Patients receive rituximab IV on day 1. On days 2 and 3, patients receive carboplatin intra-arterially over 10 minutes, cyclophosphamide IV over 10 minutes, and etoposide or etoposide phosphate IV over 10 minutes in conjunction with blood-brain barrier disruption. Patients also receive high-dose sodium thiosulfate IV over 15 minutes administered 4 and 8 hours after carboplatin on days 2 and 3 and intraventricular or intrathecal cytarabine on day 14. Beginning 48 hours after the last dose of chemotherapy, patients receive filgrastim (G-CSF)* subcutaneously (SC) daily for 7-10 days or until blood counts recover. Treatment repeats every 4 weeks for up to 12 courses.

NOTE: * Alternatively, patients may receive a single dose of pegfilgrastim SC, administered 48 hours after the completion of chemotherapy

Patients with intraocular lymphoma also receive methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit lamp exam; once weekly for 1 month; and then monthly for 1 year.

Quality of life is assessed at baseline, every 3 months during treatment, at 30 days, every 6 months for 1 year, and then annually thereafter.

Patients are followed monthly for 3 months, every 2 months for 8 months, every 3 months for 1 year, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 11-25 patients will be accrued for this study within 2-3 years.

Open or close this module Conditions
Conditions: Drug Toxicity
Thrombocytopenia
intraocular lymphoma
primary central nervous system lymphoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model:
Number of Arms:
Masking: (masked roles unspecified)
Enrollment:
Open or close this module Arms and Interventions
Intervention Details:
Drug: carboplatin
Drug: cyclophosphamide
Drug: cytarabine
Drug: etoposide
Drug: etoposide phosphate
Drug: filgrastim
Drug: pegfilgrastim
Drug: rituximab
Drug: sodium thiosulfate
Procedure: antibody therapy
Procedure: biological response modifier therapy
Procedure: chemoprotection
Procedure: chemotherapy
Procedure: colony-stimulating factor therapy
Procedure: complications of therapy assessment/management
Procedure: cytokine therapy
Procedure: monoclonal antibody therapy
Procedure: supportive care/therapy
Open or close this module Outcome Measures
Open or close this module Eligibility
Minimum Age: 1 Year
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis
  • CD20 positive disease
  • Progressive or relapsed disease during or after completion of prior methotrexate-based chemotherapy
  • No systemic lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 months to 75 years

Performance status

  • ECOG 0-3 OR
  • Karnofsky 30-100%

Life expectancy

  • Not specified

Hematopoietic

  • Hematocrit at least 25% (transfusion or epoetin alfa allowed)
  • Absolute granulocyte count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3 OR at least lower limit of normal

Hepatic

  • Bilirubin no greater than 2.0 times upper limit of normal

Renal

  • Creatinine less than 1.8 mg/dL
  • Creatinine clearance at least 30 mL/min

Cardiovascular

  • Adequate cardiac function to tolerate general anesthesia

Pulmonary

  • Adequate pulmonary function to tolerate general anesthesia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 2 months before and during study participation
  • No known allergy to study agents
  • HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Prior radiotherapy allowed

Surgery

  • Prior surgery or biopsy allowed
Open or close this module Contacts/Locations
Study Officials: Edward A. Neuwelt, MD
Principal Investigator
Oregon Health and Science University
Locations: United States, Ohio
Cleveland Clinic Taussig Cancer Center
[Recruiting]
Cleveland, Ohio, United States, 44195
Contact:Contact: Gene H. Barnett, MD 216-445-1379 barnett@neus.ccf.org
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
[Recruiting]
Columbus, Ohio, United States, 43210
Contact:Contact: John McGregor, MD 614-293-5440
United States, Oregon
Cancer Institute at Oregon Health and Science University
[Recruiting]
Portland, Oregon, United States, 97239-3098
Contact:Contact: Edward A. Neuwelt, MD 503-494-5626 Neuwelte@ohsu.edu
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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