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

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
procarbazine hydrochloride
thalidomide
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Central Illinois
  • CCOP - Southeast Cancer Control Consortium
  • Wake Forest University Comprehensive Cancer Center
  • CCOP - Greenville
  • CCOP - Upstate Carolina

Outcomes

Primary Outcome Measures

Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2004
Last Updated
September 7, 2021
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00079092
Brief Title
Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma
Official Title
A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2004 (Actual)
Primary Completion Date
March 21, 2006 (Actual)
Study Completion Date
March 21, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
recurrent adult brain tumor, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult mixed glioma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
procarbazine hydrochloride
Intervention Type
Drug
Intervention Name(s)
thalidomide
Primary Outcome Measure Information:
Title
Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
Secondary Outcome Measure Information:
Title
Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion
Title
Overall survival by follow-up form at study completion
Title
Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
Title
Toxicity by evaluation form at baseline, pre-odd cycles, and study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn J. Lesser, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward G. Shaw, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Volker W. Stieber, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534-9479
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States

12. IPD Sharing Statement

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

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