DepoCyt Plus Temozolomide in Patients With Neoplastic Meningitis
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|ClinicalTrials.gov Identifier: NCT00515788|
Recruitment Status : Terminated (Study terminated due to slow accrual with no expansion to additional phase.)
First Posted : August 14, 2007
Last Update Posted : March 12, 2012
- To determine the safety, tolerability and maximum tolerated dose (MTD) of oral temozolomide using a 7 days on and 7 days off regimen combined with intrathecal liposomal cytarabine (DepoCyt) in patients with neoplastic meningitis from solid tumors and systemic lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Neoplastic Meningitis||Drug: DepoCyt Drug: Temozolomide||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Temozolomide and Intrathecal DepoCyt in Patients With Neoplastic Meningitis|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: DepoCyt + Temozolomide
DepoCyt Starting 50 mg Intrathecal Day 1 every 14 days for 12 weeks (6 treatments), then every 28 days for 40 weeks (10 treatments). Temozolomide 100 mg/m^2 by mouth daily for 7 days every 14 days.
Starting dose of 50 mg Intrathecal on Day 1 every 14 days for a total of 12 weeks (6 treatments). After the first 12 weeks, 50 mg Intrathecal on Day 1 every 28 days for 40 weeks (10 treatments).
100 mg/m^2 (capsules) by mouth daily for 7 consecutive days every 14 days.
Other Name: Temodar
- Maximum Tolerated Dose (MTD) for the combination of Temozolomide and DepoCyt [ Time Frame: 28 days ]The MTD is the dose at which 0/3 or 1/6 participants experience Dose Limiting Toxicity (DLT) with the next higher dose having at least 2/3 or 2/6 participants encountering DLT. MTD based on the assessment of DLT during the first 28 days of treatment on the regimen.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515788
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Morris D. Groves, MD||M.D. Anderson Cancer Center|