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Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00079092
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : April 19, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: procarbazine hydrochloride Drug: thalidomide Phase 2

Detailed Description:



  • Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine.


  • 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
Actual Study Start Date : January 2004
Actual Primary Completion Date : March 21, 2006
Actual Study Completion Date : March 21, 2006

Primary Outcome Measures :
  1. Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion

Secondary Outcome Measures :
  1. Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion
  2. Overall survival by follow-up form at study completion
  3. Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
  4. Toxicity by evaluation form at baseline, pre-odd cycles, and study completion

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 2 months


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3


  • Bilirubin ≤ 1.5 mg/dL
  • Transaminases ≤ 4 times upper limit of normal


  • Creatinine ≤ 1.7 mg/dL


  • 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


Biologic therapy

  • No prior thalidomide
  • No concurrent prophylactic filgrastim (G-CSF)


  • 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


  • See Disease Characteristics
  • At least 3 months since prior radiotherapy


  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00079092

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United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
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Principal Investigator: Glenn J. Lesser, MD Wake Forest University Health Sciences
Study Chair: Edward G. Shaw, MD Wake Forest University Health Sciences
Principal Investigator: Volker W. Stieber, MD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences Identifier: NCT00079092    
Other Study ID Numbers: REBACDR0000354204
First Posted: March 9, 2004    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: August 2009
Keywords provided by Wake Forest University Health Sciences:
recurrent adult brain tumor
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents