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


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Glenn J. Lesser, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Federal Government

Study ID:

CDR0000354204

NCT ID:

NCT00079092

Start Date:

January 2004

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult glioblastoma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - GreenvilleGreenville, South Carolina  29615
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096