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Brain and Central Nervous System TumorsPhase 2NCT00006656

Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

A Phase 2 study testing carmustine in ethanol and conventional surgery in people with Brain and Central Nervous System Tumors, run by Direct Therapeutics at 12 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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 patients who have progressive or recurrent glioblastoma multiforme. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
carmustine in ethanol and conventional surgery
Type of treatment
Surgery or procedure
How many people
Not given
Where
12 sitesUnited States
Study dates
Jun 2000to not given
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically proven supratentorial malignant glioblastoma multiforme
  • Clear evidence of disease progression by MRI
  • Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated)
  • Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm
  • No brainstem (pons or medulla) or midbrain (mesencephalon) involvement
  • No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve
  • No tumor extension into the ventricular system
  • Tumor volume no greater than 33.4 cm3
  • At least one prior radiotherapy

PATIENT CHARACTERISTICS:

Age:

  • 18 to 75

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
  • No evidence of bleeding diathesis

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT/SGPT no greater than 2.5 times normal

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 40 mL/min
  • BUN no greater than 30 mg/dL

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active uncontrolled infection
  • Afebrile unless fever due to presence of tumor
  • No other concurrent serious medical or psychiatric illness that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior intracranial brachytherapy

Surgery:

  • Recovered from any prior surgery

Other:

  • No prior anticoagulants
  • No other concurrent investigational agents

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • University of Colorado Cancer Center

    Denver, Colorado, 80262

  • John F. Kennedy Medical Center

    Edison, New Jersey, 08820

  • Evanston Northwestern Health Care

    Evanston, Illinois, 60201

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Massey Cancer Center

    Richmond, Virginia, 23298-0631

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

  • Stanford University Medical Center

    Stanford, California, 94305-5408

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9416

Other trials in United States

About this study

Official title: A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme

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 patients who have progressive or recurrent glioblastoma multiforme.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of intratumoral carmustine in ethanol (DTI-015) in patients with unresectable recurrent glioblastoma multiforme. (Phase I of this study closed to accrual as of 01/15/2002.)
  • Determine the qualitative and quantitative toxicity of this regimen in these patients.
  • Assess the activity of this regimen in these patients.
  • Estimate peripheral blood carmustine levels in these patients treated with this regimen.

OUTLINE: This is a dose-escalation, multicenter study.

Patients receive carmustine in ethanol (DTI-015) intratumorally over 5 minutes during stereotactic biopsy or open craniotomy.

Cohorts of 3-6 patients receive escalating doses of DTI-015 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. (Phase I of this study closed to accrual as of 01/15/2002.)

Additional patients then receive treatment with DTI-015 at the recommended phase II dose.

Patients are followed at 4, 8, and 12 weeks and then every 1-3 months until disease progression.

PROJECTED ACCRUAL: A total of 12 patients were accrued for phase I of this study and approximately 14-18 patients will be accrued for phase II of this study. (Phase I of this study closed to accrual as of 01/15/2002.)

Being tested
carmustine in ethanol, conventional surgery
Keywords
recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, 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 startJun 2000

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
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006656
Sponsor's protocol ID
CDR0000068207
Other IDs
DTI-9901, UCMC-00042402, NCI-V00-1623
Status last verified
Aug 2003
First submitted
6 Dec 2000
Last updated
6 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carmustine in ethanol and conventional surgery in people with Brain and Central Nervous System Tumors, run by Direct Therapeutics at 12 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: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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?

Results are not available in the source record.

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 NCT00006656.

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 6 Nov 2013.

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