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Brain and Central Nervous System TumorsPhase 1/2NCT00004004

Procarbazine in Treating Patients With Recurrent Brain Tumor

A Phase 1/2 study testing procarbazine hydrochloride in people with Brain and Central Nervous System Tumors, run by New Approaches to Brain Tumor Therapy Consortium at 10 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. PURPOSE: Phase I/II trial to study the effectiveness of procarbazine in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme following… 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?
procarbazine hydrochloride
How many people
Not given
Where
10 sitesUnited States
Study dates
Jul 1999to Aug 2003
Phase
Phase 1/2
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 proven malignant glioma of one of the following types:
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme
  • Progressive or recurrent disease after radiotherapy with or without chemotherapy
  • Measurable disease by serial MR or CT

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • Greater than 2 months

Hematopoietic:

  • Absolute neutrophil count at least 1500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • SGPT/SGOT no greater than 4 times upper limit of normal

Renal:

  • Creatinine no greater than 1.7 mg/dL

Other:

  • No serious concurrent infection
  • No other illness that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No prior malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent filgrastim (G-CSF) during the first course

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior chemotherapy regimen
  • At least 3 weeks since prior chemotherapy (at least 6 weeks since prior nitrosoureas)
  • No more than 2 prior courses of carmustine or lomustine and no greater than 460 mg/m2 or 220 mg/m2, respectively
  • No prior procarbazine

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • At least 3 months since prior radiotherapy

Surgery:

  • Prior surgery allowed

Other:

  • Recovered from toxicity of prior therapy
  • At least 10 days since prior anticonvulsants for patients in Arm II
  • No concurrent investigational agents
  • No concurrent ethanol, ephedrine, isoproterenol, epinephrine, tricyclic antidepressants, paragyliline, narcotic analgesics, antihistamines, phenothiazines, hypotensives, or barbiturates
  • At least 14 days since prior antidepressants (e.g., SSRI and/or MAO inhibitor)
  • Must avoid foods high in tyramine (i.e., dark beer, wine, yogurt, cheese, bananas)

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

Other trials in United States

About this study

Official title: A Phase I/II Study of Oral Procarbazine in the Treatment of Recurrent High Grade Astrocytomas

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

PURPOSE: Phase I/II trial to study the effectiveness of procarbazine in treating patients who have progressive or recurrent astrocytoma, oligodendroglioma, or glioblastoma multiforme following treatment with radiation therapy.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of oral procarbazine when administered to patients with recurrent glioma receiving or not receiving anticonvulsants metabolized by the P450 hepatic enzyme complex.
  • Determine the pharmacokinetics of oral procarbazine, including any effects of hepatic enzyme inducing drugs, in these patients.
  • Assess the response rate to procarbazine in these patients.
  • Evaluate this regimen in terms of overall survival and duration of disease free survival in these patients.
  • Evaluate the toxicity of this regimen in these patients.

OUTLINE: Phase I of this study is a dose escalation study. Patients are stratified according to concurrent use of anticonvulsant drugs that induce cytochrome P450 (yes vs no drugs or modest-induction drugs).

  • Phase I: Patients receive oral procarbazine once daily for 5 days. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of oral procarbazine until the maximum tolerated dose (MTD) is determined.

  • Phase II: Once the MTD is determined, patients receive procarbazine as in Phase I.

Patients are followed every 2 months until death.

PROJECTED ACCRUAL: A total of 24-35 patients will be accrued for this study.

Being tested
procarbazine hydrochloride
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Gliosarcoma

What participants receive

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

  • procarbazine hydrochlorideDrug

Timeline

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

  1. First posted20 Aug 2003 (estimated)
  2. Study startJul 1999
  3. Study completionAug 2003

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 1/2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004004
Sponsor's protocol ID
CDR0000067214
Other IDs
NABTT-9901, JHOC-NABTT-9901
Status last verified
May 2007
First submitted
1 Nov 1999
Last updated
21 Jun 2013
Results posted
No

Publications

  • He X, Batchelor TT, Grossman S, Supko JG; New Approaches to Brain Tumor Therapy (NABTT) CNS Consortium. Determination of procarbazine in human plasma by liquid chromatography with electrospray ionization mass spectrometry. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Jan 25;799(2):281-91. doi: 10.1016/j.jchromb.2003.10.061.

    PubMed 14670747

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing procarbazine hydrochloride in people with Brain and Central Nervous System Tumors, run by New Approaches to Brain Tumor Therapy Consortium at 10 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 21 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 10 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 NCT00004004, 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 21 Jun 2013.

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