Clinical trial NCT00079092: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-03-09
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion
Secondary outcomes:
measure: Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion
measure: Overall survival by follow-up form at study completion
measure: Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion
measure: Toxicity by evaluation form at baseline, pre-odd cycles, and study completion
Other outcomes:
Locations:
city: Decatur
country: United States
facility: CCOP - Central Illinois
state: Illinois
city: Goldsboro
country: United States
facility: CCOP - Southeast Cancer Control Consortium
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
city: Greenville
country: United States
facility: CCOP - Greenville
state: South Carolina
city: Spartanburg
country: United States
facility: CCOP - Upstate Carolina
state: South Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Glenn J. Lesser, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Edward G. Shaw, MD
role: STUDY_CHAIR
affiliation: Wake Forest University Health Sciences
name: Volker W. Stieber, MD
role: PRINCIPAL_INVESTIGATOR
References: