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

NCT ID: NCT00079092

Last Updated: 2021-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-01
• Study Completion Date: 2006-03-21

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.

Conditions

Brain and Central Nervous System Tumors

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

procarbazine hydrochloride

Intervention Type: DRUG

thalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glenn J. Lesser, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Edward G. Shaw, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Volker W. Stieber, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

CCOP - Central Illinois

Decatur, Illinois, United States

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, United States

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

CCOP - Greenville

Greenville, South Carolina, United States

CCOP - Upstate Carolina

Spartanburg, South Carolina, United States

Countries

United States

Other Identifiers

CCCWFU-91202

Identifier Type: -

Identifier Source: secondary_id

NCI-6358

Identifier Type: -

Identifier Source: secondary_id

REBACDR0000354204

Identifier Type: -

Identifier Source: org_study_id