Treating Patients With Recurrent PCNSL With Carboplatin/BBBD and Adding Rituxan To The Treatment Regimen

This study has been terminated.

( Lack of accrual )

Study NCT00074165 Information provided by OHSU Knight Cancer Institute

First Received on December 10, 2003. Last Updated on November 21, 2011 History of Changes

Results First Received: October 10, 2011

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Brain and Central Nervous System Tumors Drug/Agent Toxicity by Tissue/Organ Lymphoma Thrombocytopenia
Interventions:	Drug: Rituxan Drug: Cyclophosphamide Drug: Etoposide Drug: Etoposide phosphate Drug: Carboplatin Drug: Sodium thiosulfate Drug: Neupogen Drug: Neulasta Drug: Cytarabine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Rituximab and Carboplatin	Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2

Participant Flow: Overall Study

	Rituximab and Carboplatin
STARTED	17
COMPLETED	17
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Rituximab and Carboplatin	Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2

Baseline Measures

	Rituximab and Carboplatin
Number of Participants [units: participants]	17
Age [units: participants]
<=18 years	0
Between 18 and 65 years	12
>=65 years	5
Age [units: years] Mean ± Standard Deviation	55.235 ± 12.799
Gender [units: participants]
Female	8
Male	9
Region of Enrollment [units: participants]
United States	17

Outcome Measures

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1. Primary:

Number of Participants With a Complete Response Rate to Chemotherapy Regimen Assessed by Radiographic Response at 2 Years. [ Time Frame: 2 years ]

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2. Secondary:

Number of Participants With Overall Survival Assessed by Clinical and Radiographic Response [ Time Frame: 5 years ]

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3. Secondary:

Progression-free Survival Assessed by Clinical and Radiographic Response From First Day of Treatment Until Tumor Progression [ Time Frame: 5 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Quality of Life Assessed by EORTC QOL Before Treatment and Then Every 3 Months [ Time Frame: 5 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Ototoxicity Assessed by Audiology Hearing Test Done Monthly During Treatment [ Time Frame: 2 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

6. Secondary:

Effect of Sodium Thiosulfate (STS) on Granulocytes and Erythrocytes Assessed by Complete Blood Count Lab Values Done Weekly During Treatment [ Time Frame: 2 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr. Edward Neuwelt
Organization: OHSU Knight Cancer Institute
phone: 503-494-5626
e-mail: neuwelte@ohsu.edu

No publications provided

Responsible Party:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00074165 History of Changes
Other Study ID Numbers:	OHSU-641, 5R01CA137488-15, ONC-02059-LX, 641, 7465
Study First Received:	December 10, 2003
Results First Received:	October 10, 2011
Last Updated:	November 21, 2011
Health Authority:	United States: Institutional Review Board