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Brain and Central Nervous System TumorsPhase 2NCT00047294

Temozolomide, Thalidomide, and Celecoxib Following Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

A Phase 2 study testing celecoxib, temozolomide and thalidomide in people with Brain and Central Nervous System Tumors, run by Dana-Farber Cancer Institute at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
celecoxib, temozolomide and thalidomide
Type of treatment
Surgery or procedure
How many people
Not given
Where
4 sitesUnited States
Study dates
Apr 2001to Sep 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed supratentorial glioblastoma multiforme or gliosarcoma
  • Completed standard external beam radiotherapy within the past 5 weeks
  • Stable disease by MRI or CT scan

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • More than 4 months

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • 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

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

  • Must participate in System for Thalidomide Education and Prescribing Safety program
  • No peripheral neuropathy grade 2 or greater
  • No active infection
  • No concurrent illness that may obscure toxicity or dangerously alter drug metabolism
  • No other serious concurrent illness
  • No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • 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 thalidomide
  • No concurrent immunotherapy
  • No concurrent prophylactic filgrastim (G-CSF)

Chemotherapy

  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy
  • Concurrent corticosteroids must be at stable or decreasing dose over the past 7 days

Radiotherapy

  • See Disease Characteristics
  • No concurrent radiotherapy

Surgery

  • No concurrent surgery

Other

  • No other concurrent anticancer therapy
  • No other concurrent investigational agents

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

Official title: Phase II Study Of Temozolomide, Thalidomide And Celecoxib In Patients With Newly Diagnosed Glioblastoma Multiforme In The Post-Radiation Setting

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide and celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may increase the effectiveness of temozolomide by making tumor cells more sensitive to the drug.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide, thalidomide, and celecoxib following radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Read the detailed description

OBJECTIVES:

  • Determine the efficacy of adjuvant temozolomide, thalidomide, and celecoxib after radiotherapy, in terms of time to tumor progression and overall survival, in patients with newly diagnosed glioblastoma multiforme.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral temozolomide once daily on days 1-5 and oral thalidomide once daily and oral celecoxib twice daily on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Keywords
adult mixed glioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioma, Glioblastoma, Gliosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001
  3. Primary completionMar 2005
  4. Study completionSep 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00047294
Sponsor's protocol ID
00302
Other IDs
P30CA006516, CDR0000257587, NCI-G02-2118, CELGENE-2000-P-002521/1
Status last verified
May 2005
First submitted
3 Oct 2002
Last updated
11 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kesari S, Schiff D, Henson JW, Muzikansky A, Gigas DC, Doherty L, Batchelor TT, Longtine JA, Ligon KL, Weaver S, Laforme A, Ramakrishna N, Black PM, Drappatz J, Ciampa A, Folkman J, Kieran M, Wen PY. Phase II study of temozolomide, thalidomide, and celecoxib for newly diagnosed glioblastoma in adults. Neuro Oncol. 2008 Jun;10(3):300-8. doi: 10.1215/15228517-2008-005. Epub 2008 Apr 10.

    PubMed 18403492

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing celecoxib, temozolomide and thalidomide in people with Brain and Central Nervous System Tumors, run by Dana-Farber Cancer Institute at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00047294, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.

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