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Brain and Central Nervous System TumorsPhase 1NCT00002971

O(6)-Benzylguanine in Treating Patients With Malignant Glioma

A Phase 1 study testing O6-benzylguanine in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 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 trial to study the effectiveness of O(6)-benzylguanine given before surgery to patients who have malignant glioma. 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?
O6-benzylguanine
How many people
Not given
Where
9 sitesUnited States
Study dates
19 Jun 1997to 1 Jan 2009
Phase
Phase 1
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:

  • Must be undergoing a diagnostic/therapeutic craniotomy for biopsy/resection of recurrent or newly diagnosed (or presumed) cerebral anaplastic astrocytoma or glioblastoma multiforme
  • Patients undergoing stereotactic biopsy or partial resection are eligible

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • SWOG 0-2 OR
  • Karnofsky 60-100%

Hematopoietic:

  • WBC at least 3,500/mm3
  • Absolute neutrophil count at least 1,800/mm3
  • Platelet count at least 125,000/mm3
  • Hemoglobin at least 9 g/dL

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT less than 2 times upper limit of normal

Renal:

  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 70 mL/min

Cardiovascular:

  • No cardiovascular illnesses that cannot be adequately controlled with
  • appropriate therapy or would increase risk, e.g.:
  • Severe cardiac disease such as uncontrolled arrhythmias or conduction
  • defects
  • Major problems with edema (e.g., residual leg swelling from deep venous
  • thrombosis)
  • Recent coronary artery disease
  • Poorly controlled hypertension (systolic pressure greater than 180 mm Hg,
  • diastolic pressure greater than 110 mm Hg)

Other:

  • No other medical illnesses that cannot be adequately controlled with
  • appropriate therapy or would increase risk, e.g.:
  • Major problems with edema (e.g., Cushing's syndrome)
  • Major psychiatric illness
  • No other malignancy requiring active therapy
  • Not pregnant or nursing
  • Fertile patients must us effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Must have failed or received no prior treatment with a nitrosourea,
  • procarbazine, or temozolomide
  • No prior O6-benzylguanine
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 6 weeks since prior radiotherapy
  • No prior radiotherapy to greater than 10-20% of bone marrow

Other:

  • No concurrent therapy for any other malignancy
  • At least 2 weeks since other prior investigational drug

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0752

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213-3489

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • UCSF Cancer Center and Cancer Research Institute

    San Francisco, California, 94143-0128

Other trials in United States

About this study

Official title: A Phase I Trial of Pre-Surgical O6-Benzylguanine in the Treatment of Patients With Malignant Glioma

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

PURPOSE: Phase I trial to study the effectiveness of O(6)-benzylguanine given before surgery to patients who have malignant glioma.

Read the detailed description

OBJECTIVES:

  • Determine the dose of O6-benzylguanine (O6-BG) that produces total depletion of tumor O6-alkylguanine-DNA alkyltransferase (AGT) levels in more than 90% of patients with cerebral anaplastic astrocytoma or glioblastoma multiforme.
  • Determine the qualitative and quantitative toxicities of O6-BG in this patient population.

OUTLINE: This is a dose escalation study.

Part I: The first cohort of 10 patients receives O6-benzylguanine (O6-BG) IV over 1 hour at dose level 1 beginning 6 hours prior to surgery. If at least 3 of 10 patients in the first cohort have detectable levels of O6-alkylguanine-DNA alkyltransferase (AGT), then a second cohort of 10 patients receives O6-BG as above at dose level 2. Dose escalation continues until at least 8 of 10 patients have undetectable AGT activity. At this point, 4 additional patients are accrued. If at least 11 of 14 patients at this dose level have undetectable levels of AGT, then this dose level constitutes the biologic modulatory dose of O6-BG. If less than 11 of 14 patients have undetectable levels of AGT, then 10 additional patients are treated at a higher dose. If at any time 3 or more patients at a dose level have detectable AGT activity, accrual is stopped at that dose level and patients are treated at the next higher dose level. (Part I closed to accrual effective 7/10/2000)

Part II: An additional cohort of 14 patients receives O6-BG at dose level 5 beginning 18 hours prior to surgery.

PROJECTED ACCRUAL: Part I of this study closed to accrual effective 7/10/2000. A total of 14 patients will be accrued for part II of this study at a rate of 3 patients per month.

Being tested
O6-benzylguanine
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Gliosarcoma

What participants receive

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

  • O6-benzylguanineDrug

Timeline

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

  1. First posted5 May 2003 (estimated)
  2. Study start19 Jun 1997
  3. Primary completion20 Feb 2003
  4. Study completion1 Jan 2009

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
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002971
Sponsor's protocol ID
NABTC-9702
Other IDs
CDR0000065479, NCI-T96-0103
Status last verified
Jun 2018
First submitted
1 Nov 1999
Last updated
27 Jun 2018
Results posted
No
FDA-regulated drug
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing O6-benzylguanine in people with Brain and Central Nervous System Tumors, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 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 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 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.

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 NCT00002971.

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 Jun 2018.

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