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Brain and Central Nervous System TumorsPhase 2NCT00039468

Thalidomide and Irinotecan in Treating Patients With Glioblastoma Multiforme Who Have Undergone Radiation Therapy

A Phase 2 study testing irinotecan hydrochloride and thalidomide in people with Brain and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical Center at 2 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: Thalidomide may stop the growth of glioblastoma multiforme 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 with irinotecan may kill any tumor cells remaining after radiation therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
irinotecan hydrochloride and thalidomide
How many people
26 participants
Where
2 sitesUnited States
Study dates
Mar 2002to Feb 2008
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed glioblastoma multiforme (GBM)
  • Recurrent disease allowed
  • Evaluable disease on contrast-enhanced MRI
  • Prior external beam radiotherapy required

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST or ALT no greater than 5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No significant cardiac disease
  • No uncontrolled high blood pressure
  • No unstable angina
  • No congestive heart failure
  • No myocardial infarction within the past 3 months
  • No serious cardiac arrhythmias

Gastrointestinal:

  • Able to take oral medication
  • No gastrointestinal abnormalities
  • No requirement for IV alimentation
  • No active peptic ulcer disease

Other:

  • No active infection
  • No serious uncontrolled medical disorder
  • No dementia or significantly altered mental status that would preclude study
  • No known hypersensitivity to irinotecan or thalidomide
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception, including 1 highly effective method, at least 1 month before, during, and for 1 month after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior thalidomide

Chemotherapy:

  • No prior irinotecan
  • At least 4 weeks since other prior chemotherapy (and demonstrated evidence of disease progression or relapse)

Endocrine therapy:

  • Concurrent corticosteroids allowed if on a stable or decreasing dose for at least 1 week prior to study
  • No concurrent hormonal therapy for GBM

Radiotherapy:

  • See Disease Characteristics
  • No concurrent radiotherapy for GBM

Surgery:

  • No prior surgical procedures affecting absorption

Other:

  • No other concurrent anticancer investigational agents for GBM
  • No concurrent cytochrome P450 inhibitors, including the following:
  • Nefazodone
  • Fluvoxamine
  • Fluoxetine
  • Sertraline
  • Paroxetine
  • Venlafaxine
  • Ketoconazole
  • Itraconazole
  • Fluconazole
  • Cimetadine
  • Clarithromycin
  • Diltiazem
  • Erythromycin
  • Protease inhibitors

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University

    Columbus, Ohio, 43210-1240

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

Other trials in United States

About this study

Official title: A Phase II Study Of Thalidomide And CPT-11 (IRINOTECAN) Following Radiotherapy For Glioblastoma Multiforme

RATIONALE: Thalidomide may stop the growth of glioblastoma multiforme 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 with irinotecan may kill any tumor cells remaining after radiation therapy.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide with irinotecan in treating patients who have glioblastoma multiforme that has been treated with radiation therapy.

Read the detailed description

OBJECTIVES:

  • Determine the response rate of patients with glioblastoma multiforme treated with thalidomide and irinotecan after radiotherapy.
  • Determine the preliminary efficacy of this regimen in these patients.
  • Determine the disease-free survival and overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Assess the quality of life of patients treated with this regimen.

OUTLINE: Beginning 2-4 weeks after completion of radiotherapy, patients receive irinotecan IV over 90 minutes on day 1. Patients also receive oral thalidomide daily. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, 1 week after the first course, prior to all subsequent courses, and then after course 6.

Patients are followed for 5 years.

PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study.

Keywords
adult glioblastoma, recurrent adult brain tumor, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Glioblastoma, Brain Neoplasms, Gliosarcoma

What participants receive

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response

    To evaluate the response rate and hence preliminary efficacy of Irinotecan and Thalidomide following radiotherapy in the treatment of newly diagnosed or relapsed glioblastoma multiforme.

    Measured: 2 years

Secondary outcomes (1)

  1. Toxicity / QOL / Survival

    To evaluate 1) toxicity 2) quality of life 3) disease free survival and 4) overall survival of patients treated with this combination.

    Measured: 2 years

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 startMar 2002
  3. Primary completionSep 2007
  4. Study completionFeb 2008

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
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00039468
Sponsor's protocol ID
D0134
Other IDs
DMS-15615, NCI-G02-2078
Status last verified
Oct 2011
First submitted
6 Jun 2002
Last updated
27 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Fadul CE, Kingman LS, Meyer LP, Cole BF, Eskey CJ, Rhodes CH, Roberts DW, Newton HB, Pipas JM. A phase II study of thalidomide and irinotecan for treatment of glioblastoma multiforme. J Neurooncol. 2008 Nov;90(2):229-35. doi: 10.1007/s11060-008-9655-9. Epub 2008 Jul 26.

    PubMed 18661102

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing irinotecan hydrochloride and thalidomide in people with Brain and Central Nervous System Tumors, run by Dartmouth-Hitchcock Medical Center at 2 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 27 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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.

What does the primary outcome measure?

Response (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00039468, 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 27 Oct 2011.

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