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Thalidomide, Celecoxib, and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Malignant Glioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047281
First Posted: January 27, 2003
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
Schering-Plough
Celgene
Information provided by (Responsible Party):
Patrick Y. Wen, MD, Dana-Farber Cancer Institute
  Purpose

RATIONALE: Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide and celecoxib with etoposide and cyclophosphamide may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and celecoxib with etoposide and cyclophosphamide in treating patients who have relapsed or refractory malignant glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors Drug: celecoxib Drug: cyclophosphamide Drug: etoposide Drug: thalidomide Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial Of Oral Thalidomide, Celecoxib, Etoposide And Cyclophosphamide In Adult Patients With Relapsed Or Progressive Malignant Gliomas

Resource links provided by NLM:


Further study details as provided by Patrick Y. Wen, MD, Dana-Farber Cancer Institute:

Actual Study Start Date: March 2004
Study Completion Date: February 2006
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the efficacy of thalidomide, celecoxib, etoposide, and cyclophosphamide, in terms of 6-month progression-free survival, in patients with relapsed or refractory malignant glioma.
  • Determine the overall survival of patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the radiographic response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily and oral celecoxib twice daily on days 1-42, oral etoposide once daily on days 1-21, and oral cyclophosphamide once daily on days 22-42. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 48 patients (32 with glioblastoma multiforme and 16 with anaplastic glioma) will be accrued for this study within 2 years.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed intracranial malignant glioma, including glioblastoma multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligoastrocytoma, or malignant astrocytoma not otherwise specified
  • Unequivocal evidence of relapsed or refractory disease by MRI or CT scan and/or tumor resection

    • Steroid therapy prior to MRI or CT scan must have been at a stable dose for at least 5 days
    • Failed prior radiotherapy

      • Must have confirmation of true progression rather than radiation necrosis if previously treated with interstitial brachytherapy or stereotactic radiosurgery

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 2 months

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • Hemoglobin greater than 9 g/dL
  • No history of bleeding disorder

Hepatic

  • Bilirubin less than 1.5 mg/dL
  • SGPT less than 2.5 times normal
  • Alkaline phosphatase less than 2.5 times normal

Renal

  • Creatinine less than 1.5 times upper limit of normal (ULN) OR
  • BUN less than 1.5 times ULN

Cardiovascular

  • No deep vein thrombosis within the past 3 weeks (must be clinically stable)

Pulmonary

  • No pulmonary embolism within the past 3 weeks (must be clinically stable)

Other

  • No peripheral neuropathy grade 2 or greater
  • No active infection
  • No other serious concurrent medical illness
  • No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • Must participate in the System for Thalidomide Education and Prescribing Safety program
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior oral thalidomide or celecoxib for more than 2 months duration

Chemotherapy

  • No prior oral etoposide or cyclophosphamide for more than 2 months duration
  • Prior standard-dose IV etoposide and cyclophosphamide allowed

Endocrine therapy

  • See Disease Characteristics
  • Concurrent steroids allowed

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy

Surgery

  • See Disease Characteristics
  • Prior surgery for relapsed or refractory disease allowed
  • Recovered from prior surgery
  • No concurrent surgery

Other

  • No other concurrent investigational agents or treatment
  • No other concurrent anticancer therapy
  • Concurrent antiseizure medications allowed
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047281


Locations
United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Schering-Plough
Celgene
Investigators
Study Chair: Patrick Y. Wen, MD Dana-Farber Cancer Institute
  More Information

Responsible Party: Patrick Y. Wen, MD, Director, Center for Neuro-Oncology, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00047281     History of Changes
Other Study ID Numbers: 01-278
P30CA006516 ( U.S. NIH Grant/Contract )
CDR0000257584
NCI-G02-2117
CELGENE-2001-P-001757/3
First Submitted: October 3, 2002
First Posted: January 27, 2003
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick Y. Wen, MD, Dana-Farber Cancer Institute:
adult anaplastic astrocytoma
adult anaplastic oligodendroglioma
adult glioblastoma
adult mixed glioma
recurrent adult brain tumor
adult giant cell glioblastoma
adult gliosarcoma

Additional relevant MeSH terms:
Glioma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Cyclophosphamide
Thalidomide
Celecoxib
Etoposide phosphate
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors