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Brain and Central Nervous System TumorsPhase 2NCT00003467

Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma

A Phase 2 study testing carmustine, polifeprosan 20 with carmustine implant and surgical procedure in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site 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. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma. 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?
carmustine, polifeprosan 20 with carmustine implant and surgical procedure
Type of treatment
Surgery or procedure
How many people
68 participants
Where
1 siteUnited States
Study dates
Jan 1998to Feb 2004
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 recurrent primary low grade glioma including:
  • Fibrillary astrocytoma
  • Oligodendroglioma
  • Mixed glioma
  • Evidence of measurable enhancing or non-enhancing CNS neoplasm on MRI

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Hematocrit greater than 29%
  • Absolute neutrophil count greater than 1500/mm^3
  • Platelet count greater than 125,000/mm^3

Hepatic:

  • SGOT less than 1.5 times upper limit of normal (ULN)
  • Bilirubin less than 1.5 times ULN

Renal:

  • Creatinine less than 1.5 mg/dL
  • BUN less than 25 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy unless disease progression

Endocrine therapy:

  • Concurrent corticosteroids allowed (must be on stable dose for 1 week prior to study)
  • No concurrent immunosuppressive agents

Radiotherapy:

  • At least 4 weeks since prior radiotherapy unless disease progression

Surgery:

  • Not specified

Other:

  • No other concurrent medication that may interfere with study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase II Treatment of Adults With Recurrent Supratentorial Low Grade Glioma With Gliadel Wafers

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of Gliadel wafers (carmustine) in the treatment of recurrent supratentorial low grade glioma.
  • Assess the toxicity of this therapy in these patients.

OUTLINE: Patients are stratified by disease (fibrillary astrocytoma vs oligodendroglioma or mixed glioma).

Patients receive up to 8 Gliadel wafers (containing carmustine) implanted in the resected tumor cavity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: This study will accrue a maximum of 68 patients within 18-24 months.

Being tested
carmustine, polifeprosan 20 with carmustine implant, surgical procedure
Keywords
recurrent adult brain tumor, adult brain stem glioma, adult mixed glioma, adult anaplastic astrocytoma, adult pilocytic astrocytoma, adult oligodendroglioma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioma, Astrocytoma, Oligodendroglioma

What participants receive

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

  • carmustineDrug

  • polifeprosan 20 with carmustine implantDrug

  • surgical procedureProcedure or surgery

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 startJan 1998
  3. Study completionFeb 2004

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
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003467
Sponsor's protocol ID
1706
Other IDs
DUMC-1706-02-9R5, DUMC-1706-01-9R4, DUMC-000693-00-4, DUMC-1509-97-10, DUMC-1568-98-10R1, DUMC-1706-00-9R3, DUMC-97131, NCI-G98-1470
Status last verified
Oct 2009
First submitted
1 Nov 1999
Last updated
20 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carmustine, polifeprosan 20 with carmustine implant and surgical procedure in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site 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 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 NCT00003467.

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 20 Jun 2013.

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