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

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ClinicalTrials.gov Identifier: NCT00079092
Recruitment Status : Completed
First Posted : March 9, 2004
Last Update Posted : April 19, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Tracking Information
First Submitted Date  ICMJE March 8, 2004
First Posted Date  ICMJE March 9, 2004
Last Update Posted Date April 19, 2017
Actual Study Start Date  ICMJE January 2004
Actual Primary Completion Date March 21, 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
Official Title  ICMJE A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Brain and Central Nervous System Tumors
Intervention  ICMJE
  • Drug: procarbazine hydrochloride
  • Drug: thalidomide
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
18
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 21, 2006
Actual Primary Completion Date March 21, 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00079092
Other Study ID Numbers  ICMJE REBACDR0000354204
CCCWFU-91202
NCI-6358
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wake Forest University Health Sciences
Study Sponsor  ICMJE Wake Forest University Health Sciences
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
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
PRS Account Wake Forest University Health Sciences
Verification Date August 2009

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