Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma - Full Text View

Sponsor:	Wake Forest University Baptist Medical Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier:	NCT00079092

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: procarbazine hydrochloride Drug: thalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Trial Of Thalidomide And Procarbazine In Adults With Recurrent/Progressive Gliomas

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Thalidomide Procarbazine hydrochloride Procarbazine

U.S. FDA Resources

Further study details as provided by Wake Forest University Baptist Medical Center:

Primary Outcome Measures:

Response rate by CT scan and MRI at baseline, pre-odd cycles, and study completion [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival by CT scan, MRI, and follow up form at baseline, pre-odd cycles, and study completion [ Designated as safety issue: No ]
Overall survival by follow-up form at study completion [ Designated as safety issue: No ]
Quality of life by FACT-Br, FACIT-F and Karnofsky performance status (PS) at baseline, pre-odd cycles, and study completion [ Designated as safety issue: No ]
Toxicity by evaluation form at baseline, pre-odd cycles, and study completion [ Designated as safety issue: Yes ]

Estimated Enrollment:	55
Study Start Date:	January 2004

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079092

Locations

United States, Illinois
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
United States, North Carolina
CCOP - Southeast Cancer Control Consortium
Goldsboro, North Carolina, United States, 27534-9479
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, South Carolina
CCOP - Greenville
Greenville, South Carolina, United States, 29615
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303

Sponsors and Collaborators

Wake Forest University Baptist Medical Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Glenn J. Lesser, MD	Wake Forest University
Study Chair:	Edward G. Shaw, MD	Wake Forest University
Principal Investigator:	Volker W. Stieber, MD	Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000354204, CCCWFU-91202, NCI-6358
Study First Received:	March 8, 2004
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00079092 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Wake Forest University Baptist Medical Center:

recurrent adult brain tumor
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma

adult mixed glioma
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:

Anti-Infective Agents
Thalidomide
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Anti-Bacterial Agents
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Growth Inhibitors
Glioma
Angiogenesis Modulating Agents

Nervous System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Nervous System Diseases
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neuroectodermal Tumors
Neoplasms
Procarbazine
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Leprostatic Agents

ClinicalTrials.gov processed this record on November 27, 2009