Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor
|First Received Date ICMJE||October 4, 2000|
|Last Updated Date||July 23, 2008|
|Start Date ICMJE||May 2000|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00006358 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Temozolomide Plus Thalidomide in Treating Patients With Recurrent or Progressive Brain Tumor|
|Official Title ICMJE||Phase II Evaluation of Temozolomide (SCH52365) and Thalidomide for the Treatment of Recurrent and Progressive Glioblastoma Multiforme|
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide in treating patients who have recurrent or progressive brain tumor.
OBJECTIVES: I. Determine the efficacy of temozolomide and thalidomide in patients with recurrent or progressive supratentorial glioblastoma multiforme or gliosarcoma. II. Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 24 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then for survival.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4-5 months.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Condition ICMJE||Brain and Central Nervous System Tumors|
|Study Arm (s)||Not Provided|
|Publications *||Groves MD, Puduvalli VK, Chang SM, Conrad CA, Gilbert MR, Tremont-Lukats IW, Liu TJ, Peterson P, Schiff D, Cloughesy TF, Wen PY, Greenberg H, Abrey LE, Deangelis LM, Hess KR, Lamborn KR, Prados MD, Yung WK. A North American brain tumor consortium (NABTC 99-04) phase II trial of temozolomide plus thalidomide for recurrent glioblastoma multiforme. J Neurooncol. 2007 Feb;81(3):271-7. Epub 2006 Sep 22.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma Must have evidence of tumor recurrence or progression by MRI scan after failing prior radiotherapy Bidimensionally measurable enhancing residual disease on MRI or CT scan Prior recent resection of recurrent or progressive tumor allowed if all of the following conditions apply: Recovered from surgery Residual evaluable disease present that is not artifactual postsurgical enhancement Baseline MRI or CT scan is performed within 14 days prior to study and while on a steroid dose that has been stable for at least 5-7 days
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGPT less than 2 times normal Alkaline phosphatase less than 2 times normal Bilirubin less than 1.5 mg/dL Renal: BUN or creatinine less than 1.5 times normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use one highly effective method of contraception, AND one additional effective method of contraception for at least 4 weeks before, during, and for 8 weeks after study No peripheral neuropathy greater than grade 1 No active infection No other illness that would obscure toxicity or alter drug metabolism No other concurrent serious medical illness No other prior cancer within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior thalidomide No other concurrent biologic therapy for cancer Chemotherapy: No more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (2 weeks for vincristine and 6 weeks for nitrosoureas) No other concurrent chemotherapy for cancer Endocrine therapy: See Disease Characteristics No concurrent endocrine therapy for cancer Radiotherapy: See Disease Characteristics No concurrent radiotherapy for cancer Surgery: See Disease Characteristics No concurrent surgery for cancer Other: Recovered from prior therapy No other concurrent investigational drugs for cancer
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00006358|
|Other Study ID Numbers ICMJE||CDR0000068227, NABTC-9904|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||North American Brain Tumor Consortium|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||October 2006|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP