- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00079092
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
RATIONALE: Thalidomide may stop the growth of malignant glioma 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: This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive malignant glioma.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Decatur, Illinois, United States, 62526
- CCOP - Central Illinois
-
-
North Carolina
-
Goldsboro, North Carolina, United States, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, United States, 27157-1096
- Wake Forest University Comprehensive Cancer Center
-
-
South Carolina
-
Greenville, South Carolina, United States, 29615
- CCOP - Greenville
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Spartanburg, South Carolina, United States, 29303
- CCOP - Upstate Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion
|
Overall survival by follow-up form at study completion
|
Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
|
Toxicity by evaluation form at baseline, pre-odd cycles, and study completion
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Edward G. Shaw, MD, Wake Forest University Health Sciences
- Principal Investigator: Glenn J. Lesser, MD, Wake Forest University Health Sciences
- Principal Investigator: Volker W. Stieber, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Glioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
- Procarbazine
Other Study ID Numbers
- REBACDR0000354204
- CCCWFU-91202
- NCI-6358
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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