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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT00079092
Collaborator
National Cancer Institute (NCI) (NIH)
18
5
26.6
3.6
0.1

Study Details

Study Description

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
Phase 2

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 Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2004
Actual Primary Completion Date :
Mar 21, 2006
Actual Study Completion Date :
Mar 21, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 120 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CCOP - Central Illinois Decatur Illinois United States 62526
2 CCOP - Southeast Cancer Control Consortium Goldsboro North Carolina United States 27534-9479
3 Wake Forest University Comprehensive Cancer Center Winston-Salem North Carolina United States 27157-1096
4 CCOP - Greenville Greenville South Carolina United States 29615
5 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303

Sponsors and Collaborators

  • Wake Forest University Health Sciences
  • National Cancer Institute (NCI)

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00079092
Other Study ID Numbers:
  • REBACDR0000354204
  • CCCWFU-91202
  • NCI-6358
First Posted:
Mar 9, 2004
Last Update Posted:
Sep 9, 2021
Last Verified:
Sep 1, 2021

Study Results

No Results Posted as of Sep 9, 2021