Lonafarnib and Temozolomide in Treating Patients With Glioblastoma Multiforme That Is Recurrent or Did Not Respond to Previous Treatment With Temozolomide
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|ClinicalTrials.gov Identifier: NCT00102648|
Recruitment Status : Active, not recruiting
First Posted : February 1, 2005
Last Update Posted : June 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Malignant Supratentorial Neoplasm Recurrent Glioblastoma Recurrent Gliosarcoma||Drug: Lonafarnib Drug: Temozolomide||Phase 1|
I. To determine the maximum tolerated dose Sarasar (SCH66336, lonafarnib) when combined with Temodar (temozolomide) in an alternating week schedule.
II. To describe the toxicities of the Sarasar and Temodar combination treatment using this dosing schedule.
III. To evaluate response as measured by 6-month progression-free survival and objective tumor response.
OUTLINE: This is a dose-escalation study of lonafarnib.
Patients receive temozolomide orally (PO) once daily (QD) on days 1-7 and 15-21 and lonafarnib PO twice daily (BID) on days 8-14 and 22-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/Ib Study of Sarasar and Temodar in Patients With Recurrent or Temodar-Refractory Glioblastoma Multiforme|
|Actual Study Start Date :||December 21, 2004|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||December 1, 2022|
Experimental: Treatment (temozolomide and lonafarnib)
Patients receive temozolomide PO QD on days 1-7 and 15-21 and lonafarnib PO BID on days 8-14 and 22-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
- Maximum tolerated dose (MTD) of lonafarnib when given with temozolomide, defined as the dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT) [ Time Frame: 28 days ]
- Tolerability of regimen in patients with disease progression or recurrence during or after recent completion of treatment with temozolomide [ Time Frame: Up to 11 years ]
- Progression free survival (PFS) [ Time Frame: 6 months ]In the historical dataset, the proportion of patients remaining alive and free from progression at 6 months was 15% (95% confidence interval for ranged from 10% to 19%). We will set p0 to 15% and we will set p1 to 30% (looking for a doubling of the 6-month PFS rate). Based on these design parameters, a two-stage design would require that at least 4 of the initial 19 patients are without progression at 6 months.
- Objective response [ Time Frame: Up to 11 years ]
- Overall survival [ Time Frame: Up to 11 years ]
- Treatment-related toxicities [ Time Frame: Up to 11 years ]Treatment-related toxicity data will be collected and described.
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): NCT00102648
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||John de Groot||M.D. Anderson Cancer Center|