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Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
This study has been completed.
Study NCT00079092   Information provided by Wake Forest University Baptist Medical Center
First Received: March 8, 2004   Last Updated: August 20, 2009   History of Changes

March 8, 2004
August 20, 2009
January 2004
 
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion [ Designated as safety issue: No ]
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
Complete list of historical versions of study NCT00079092 on ClinicalTrials.gov Archive Site
  • Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion [ Designated as safety issue: No ]
  • Overall survival by follow-up form at study completion [ Designated as safety issue: No ]
  • Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion [ Designated as safety issue: No ]
  • Toxicity by evaluation form at baseline, pre-odd cycles, and study completion [ Designated as safety issue: Yes ]
  • 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
 
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.

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.

Phase II
Interventional
Treatment, Open Label
Brain and Central Nervous System Tumors
  • Drug: procarbazine hydrochloride
  • Drug: thalidomide
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
55
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00079092
 
CDR0000354204, CCCWFU-91202, NCI-6358
Wake Forest University Baptist Medical Center
National Cancer Institute (NCI)
Principal Investigator: Glenn J. Lesser, MD Wake Forest University
Study Chair: Edward G. Shaw, MD Wake Forest University
Principal Investigator: Volker W. Stieber, MD Wake Forest University
Wake Forest University Baptist Medical Center
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP