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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079092
• Other study ID #: REBACDR0000354204
• Secondary ID: CCCWFU-91202NCI-
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2004
• Est. completion date: March 21, 2006

Study information

• Verified date: September 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 21, 2006
• Est. primary completion date: March 21, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Glioma
• Nervous System Neoplasms

Intervention

Drug:
• procarbazine hydrochloride

• thalidomide

Locations

Country	Name	City	State
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Southeast Cancer Control Consortium	Goldsboro	North Carolina
United States	CCOP - Greenville	Greenville	South Carolina
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
Secondary	Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion
Secondary	Overall survival by follow-up form at study completion
Secondary	Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
Secondary	Toxicity by evaluation form at baseline, pre-odd cycles, and study completion