Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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.

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Wake Forest University Baptist Medical Center

Glenn J. Lesser, MD

Principal Investigator

Edward G. Shaw, MD

Study Chair

Volker W. Stieber, MD

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00079092
Information obtained from ClinicalTrials.gov on December 14, 2011

Back to Top