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Brain and Central Nervous System TumorsPhase 1/2NCT00005855

Efaproxiral Plus Carmustine in Treating Patients With Progressive or Recurrent Malignant Glioma

A Phase 1/2 study testing carmustine and efaproxiral in people with Brain and Central Nervous System Tumors, run by New Approaches to Brain Tumor Therapy Consortium 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. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they… 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 and efaproxiral
How many people
48 participants
Where
9 sitesUnited States
Study dates
Jul 2000to Oct 2006
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 confirmed malignant glioma that is progressive or recurrent after radiotherapy with or without chemotherapy
  • Anaplastic astrocytoma
  • Anaplastic oligodendroglioma
  • Glioblastoma multiforme
  • Prior low-grade glioma allowed provided progression has occurred after radiotherapy with or without chemotherapy and then high-grade glioma is found on biopsy
  • Measurable disease by serial MRI or CT scan

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
  • Hemoglobin at least 10 g/dL
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 3 times ULN

Renal:

  • Creatinine no greater than 2.0 mg/dL

Pulmonary:

  • Resting oxygen saturation on room air at least 90% by pulse oximetry
  • FVC, DLCO, and FEV_1 at least 50% of normal

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 3 weeks since prior investigational biologics

Chemotherapy:

  • See Disease Characteristics
  • No prior nitrosoureas for glioma
  • No more than 1 prior chemotherapy regimen
  • At least 4 weeks since prior chemotherapy
  • No prior efaproxiral

Endocrine therapy:

  • Concurrent corticosteroids (e.g., dexamethasone) allowed

Radiotherapy:

  • See Disease Characteristics
  • At least 90 days since prior radiotherapy

Surgery:

  • Not specified

Other:

  • At least 3 weeks since other prior investigational drugs or devices

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Winship Cancer Institute of Emory University

    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

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229-3900

  • H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

    Tampa, Florida, 33612-9497

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

Other trials in United States

About this study

Official title: A Phase I/II Study to Evaluate the Safety and Tolerance of Escalating Doses of RSR13 Administered With a Fixed Dose of BCNU Every Six Weeks in Patients With Recurrent Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of efaproxiral when given with carmustine and to see how well they work in treating patients with progressive or recurrent malignant glioma.

Read the detailed description

OBJECTIVES:

  • Evaluate the safety and tolerability of escalating doses of efaproxiral (RSR13) when administered concurrently with carmustine in patients with progressive or recurrent malignant glioma.
  • Determine the maximum tolerated dose (MTD) of RSR13 when administered with carmustine in this patient population.
  • Determine the pharmacokinetic profile of this regimen in these patients.
  • Estimate the efficacy of this regimen at the MTD in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter, dose-escalation study of efaproxiral (RSR13).

Patients receive RSR13 IV over 30 minutes followed 30 minutes later by carmustine IV over 1-2 hours on day 1. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.

Cohorts of 6-12 patients receive escalating doses of RSR13 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 or 5 of 12 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive treatment with RSR13 and carmustine at the recommended phase II dose.

Patients are followed at 6 weeks and then every 2 months thereafter.

PROJECTED ACCRUAL: A maximum of 48 patients will be accrued for the phase I portion of this study. A maximum of 47 patients will be accrued for the phase II portion of this study.

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

What participants receive

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

  • carmustineDrug

  • efaproxiralDrug

What is being measured

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

  1. Safety and tolerability

  2. Maximum tolerated dose

  3. Pharmacokinetic profile

  4. Efficacy

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 startJul 2000
  3. Study completionOct 2006

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
Allocation
Non-randomised
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005855
Sponsor's protocol ID
CDR0000067881
Other IDs
NABTT-9806, JHOC-NABTT-9806
Status last verified
Dec 2003
First submitted
2 Jun 2000
Last updated
21 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing carmustine and efaproxiral in people with Brain and Central Nervous System Tumors, run by New Approaches to Brain Tumor Therapy Consortium 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 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 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 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.

What does the primary outcome measure?

Safety and tolerability. The study lists 4 primary outcomes in all. 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 NCT00005855.

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; AzTrials last refreshed its copy on 27 Oct 2026.

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