Phase II Trial of Peginterferon Alpha-2b and Thalidomide in Adults With Recurrent Gliomas

This study has been completed.

Study NCT00047879 Information provided by National Institutes of Health Clinical Center (CC)

First Received on June 19, 2006. Last Updated on September 19, 2011 History of Changes

Results First Received: May 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Glioma
Interventions:	Biological: PEG-interferon alfa-2b Drug: Thalidomide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We planned to accrue 32 patients to the GBM stratum and 32 patients to the AG stratum. The accrual ceiling was 64 patients on this trial. We anticipated accruing these patients within one year of opening this study.

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

We planned to accrue 32 patients to the GBM stratum and 32 patients to the AG stratum.

The accrual ceiling was 64 patients on this trial. We anticipated accruing these patients within one year of opening this study.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Glioblastoma Multiforme Stratum	Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
Anaplastic Glioma Stratum	Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.

Participant Flow: Overall Study

	Glioblastoma Multiforme Stratum	Anaplastic Glioma Stratum
STARTED	4	3
COMPLETED	0	0
NOT COMPLETED	4	3
Progressive disease	4	3

Baseline Characteristics

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Reporting Groups

	Description
Glioblastoma Multiforme Stratum	Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
Anaplastic Glioma Stratum	Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.

Baseline Measures

	Glioblastoma Multiforme Stratum	Anaplastic Glioma Stratum	Total
Number of Participants [units: participants]	4	3	7
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	4	1	5
>=65 years	0	2	2
Age [units: years] Mean ± Standard Deviation	55.5 ± 10.85	53.67 ± 11.93	54.71 ± 10.36
Gender [units: participants]
Female	0	1	1
Male	4	2	6
Region of Enrollment [units: participants]
United States	4	3	7

Outcome Measures

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1. Primary:

Progression-free Survival [ Time Frame: 6 months ]

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2. Secondary:

Number of Participants With Complete or Partial Response [ Time Frame: 6 months ]

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3. Secondary:

The Number of Participants With Adverse Events [ Time Frame: 4 months ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Registered 7 out of 64 participants and they came off study for progressive disease around 3-4 months after starting the study.

Results Point of Contact:

Name/Title: Howard A. Fine, M.D.
Organization: National Cancer Institute, National Institutes of Health
phone: 301-402-6383
e-mail: hfine@mail.nih.gov

Publications:

Dinapoli RP, Brown LD, Arusell RM, Earle JD, O'Fallon JR, Buckner JC, Scheithauer BW, Krook JE, Tschetter LK, Maier JA, et al. Phase III comparative evaluation of PCNU and carmustine combined with radiation therapy for high-grade glioma. J Clin Oncol. 1993 Jul;11(7):1316-21.

Takamiya Y, Friedlander RM, Brem H, Malick A, Martuza RL. Inhibition of angiogenesis and growth of human nerve-sheath tumors by AGM-1470. J Neurosurg. 1993 Mar;78(3):470-6.

Fine HA, Figg WD, Jaeckle K, Wen PY, Kyritsis AP, Loeffler JS, Levin VA, Black PM, Kaplan R, Pluda JM, Yung WK. Phase II trial of the antiangiogenic agent thalidomide in patients with recurrent high-grade gliomas. J Clin Oncol. 2000 Feb;18(4):708-15.

Responsible Party:	Howard A. Fine, M.D./National Cancer Institute, National Institutes of Health
ClinicalTrials.gov Identifier:	NCT00047879 History of Changes
Obsolete Identifiers:	NCT00052650
Other Study ID Numbers:	030002, 03-C-0002, 030002
Study First Received:	June 19, 2006
Results First Received:	May 24, 2011
Last Updated:	September 19, 2011
Health Authority:	United States: Federal Government