Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00412542
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2006-12-15
Brief Title:
Thalidomide and Temozolomide or Camptothecin-11 CPT-11 in Patients With Gliomas
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase II Trial of Combination Therapy With Thalidomide and CPT-11 in Patients With Recurrent Anaplastic Gliomas or Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives
11 To determine the efficacy as measured by 6 month progression-free survival of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent andor progressive malignant gliomas
12 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11
13 To determine Thrombotic thrombocytopenic purpura TTP overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas
14 To determine changes in dynamic magnetic resonance imaging MRI as a surrogate marker for treatment effect
11 To determine the efficacy as measured by 6 month progression-free survival of therapy with thalidomide combined with CPT-11 in the treatment of patients with recurrent andor progressive malignant gliomas
12 To determine the rate of measureable clinical response in patients treated with Thalidomide and CPT-11
13 To determine Thrombotic thrombocytopenic purpura TTP overall survival and unexpected toxicity of Thalidomide and CPT-11 used in recurrent malignant gliomas
14 To determine changes in dynamic magnetic resonance imaging MRI as a surrogate marker for treatment effect
Detailed Description:
Thalidomide is a drug that interferes with the growth of blood vessels Thalidomide may help to decrease the blood supply in the tumor and make it unable to grow CPT-11 is a drug that was designed to stop cancer cells from dividing
All participants will take thalidomide capsules by mouth every evening at bedtime You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week After that you will increase the dose to 4 capsules each night for the rest of the study The dosages may be adjusted if you experience any severe side effects
In addition to thalidomide you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug This 6 week period is called a course of therapy The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years
THIS IS AN INVESTIGATIONAL STUDY Both drugs are commercially available Thalidomide and CPT-11 are FDA approved for the treatment of some cancers The combination of these drugs is investigational
Up to 78 participants will take part in this study All will be enrolled at M D Anderson
All participants will take thalidomide capsules by mouth every evening at bedtime You will begin with 1 capsule every night for the first week then increase to 2 capsules every night for a week and then 3 capsules a night for the third week After that you will increase the dose to 4 capsules each night for the rest of the study The dosages may be adjusted if you experience any severe side effects
In addition to thalidomide you will receive treatment with CPT-11 through a continuous injection into a vein over 90 minutes once a week for 4 weeks followed by 2 weeks of rest from the drug This 6 week period is called a course of therapy The courses of therapy will be repeated as long as the disease is responding to treatment for up to 2 years
THIS IS AN INVESTIGATIONAL STUDY Both drugs are commercially available Thalidomide and CPT-11 are FDA approved for the treatment of some cancers The combination of these drugs is investigational
Up to 78 participants will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None