Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	CCCWFU-91202 NCI-6358, 6358, NCT00079092

Objectives

Primary

1. Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine.

Secondary

1. Determine the progression-free survival of patients treated with this regimen.
2. Determine the overall survival of patients treated with this regimen.
3. Determine the quality of life of patients treated with this regimen.
4. Determine the toxicity of this regimen in these patients.

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• More than 2 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³

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

Expected Enrollment

A total of 23-55 patients will be accrued for this study.

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Glenn Lesser, MD, Protocol chair		Ph: 336-716-9527; 800-446-2255 Email: glesser@wfubmc.edu
Edward Shaw, MD, Protocol co-chair		Ph: 336-713-6506; 800-446-2255 Email: eshaw@wfubmc.edu
Volker Stieber, MD, Protocol co-chair		Ph: 336-713-6508 Email: vstieber@wfubmc.edu

Registry Information
Official Title		A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas
Trial Start Date		2004-01-15
Registered in ClinicalTrials.gov		NCT00079092
Date Submitted to PDQ		2004-01-20
Information Last Verified		2007-04-05
NCI Grant/Contract Number		CA12197, CA81851

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