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Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma Clinical research trials and Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma. Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma clinical trial. Participants frequently get the best healthcare available for their Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma  Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
For Condition: adult glioblastoma multiforme,adult anaplastic astrocytoma,Mixed Gliomas,adult anaplastic oligodendroglioma,recurrent adult brain tumor
Status: Recruiting
Sponsor(s): Comprehensive Cancer Center of Wake Forest University , National Cancer Institute (NCI)
Synopsis: RATIONALE: Thalidomide may stop the growth of malignantglioma by stopping blood flow to the tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with procarbazine in treating patients who have recurrent or progressive malignant glioma.
Details: OBJECTIVES: Primary - Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine. Secondary - Determine the progression-free survival of patients treated with this regimen. - Determine the overall survival of patients treated with this regimen. - Determine the quality of life of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before every odd course. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 23-55 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignant glioma - Anaplastic astrocytoma - Anaplastic oligodendroglioma - Glioblastoma multiforme - Anaplastic mixed oligoastrocytoma - Progressive or recurrent disease* after radiotherapy with or without chemotherapy NOTE: *Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible - Measurable disease by MRI or CT scan PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 60-100% Life expectancy - More than 2 months Hematopoietic - Absolute neutrophil count 1,500/mm^3 - Platelet count 100,000/mm^3 Hepatic - Bilirubin 1.5 mg/dL - Transaminases 4 times upper limit of normal Renal - Creatinine 1.7 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment - No concurrent serious infection - No other concurrent medical illness that would preclude study treatment - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - No prior thalidomide - No concurrent prophylactic filgrastim (G-CSF) Chemotherapy - See Disease Characteristics - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No prior procarbazine - No more than 2 prior chemotherapy regimens for malignant glioma Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - At least 3 months since prior radiotherapy Other - Recovered from prior therapy - More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors) - No concurrent antidepressants - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GlennLesser, Study Chair, Comprehensive Cancer Center of Wake Forest University
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
CCOP - Greenville *Recruiting*
Greenville, South Carolina, 29615
United States
Recruiting Jeffrey Giguere 864-241-6251
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1030
United States
Recruiting Edward Shaw 336-716-4647
CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem, North Carolina, 27104-4241
United States
Recruiting James Atkins 336-777-3036
Additional Information:
Study ID Numbers: CDR0000354204; CCCWFU-91202,NCI-6358
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079092
Other Mixed Gliomas Studies:
1. Tipifarnib and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
2. Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma
3. Temozolomide in Treating Patients With Recurrent Malignant Glioma
4. Fenretinide in Treating Patients With Recurrent Malignant Glioma
5. Temozolomide in Treating Patients With Recurrent Oligodendroglial Tumors
Related Studies:
Other Mixed Gliomas Clinical Trials
Other Illinois Clinical Trials
Other Decatur Clinical Trials
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
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