Carmustine Followed By Surgery in Treating Patients With Recurrent Supratentorial Malignant Glioma or Metastatic Brain Neoplasm

November 5, 2013 updated by: Direct Therapeutics

Phase I/II Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain

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 carmustine followed by surgery in treating patients who have recurrent supratentorial malignant glioma or metastatic brain neoplasm.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the extent and pattern of distribution of DNA adducts in patients with recurrent supratentorial malignant glioma or metastatic neoplasm to the brain treated with neoadjuvant intratumoral carmustine in ethanol (DTI-015) followed by tumor resection.
  • Determine the qualitative and quantitative toxicity of this treatment regimen in these patients.

OUTLINE: This is a dose escalation study.

Patients receive neoadjuvant carmustine in ethanol (DTI-015) intratumorally under stereotactic guidance 45-90 minutes prior to craniotomy and tumor resection.

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 3 or 3 of 6 patients experience dose-limiting toxicity.

Patients are followed at 4, 8, and 12 weeks, and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143-0128
        • UCSF Cancer Center and Cancer Research Institute
    • Virginia
      • Richmond, Virginia, United States, 23298-0631
        • Massey Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent supratentorial malignant glioma with clear evidence of progression by MRI

    • Glioblastoma multiforme
    • Anaplastic ependymoma
    • Anaplastic astrocytoma
    • Anaplastic oligodendroglioma OR
  • Metastatic tumor to the brain other than melanoma
  • Planned resection of tumor (must be first surgery for recurrent disease)
  • Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no greater than 33.4 cm3

  • Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution of the injected study drug

    • Tumor is spherical, spheroid, or ovoid
    • No tumors shaped into 3 or more components (e.g., multicentric or multilobulated)
    • No tumors extending into the ventricular system
    • Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured)
    • Central necrosis and/or central cystic areas allowed if an enhancing rim with a thickness of more than 5 mm is present

  • No tumors in the following locations of the brain:

    • Brainstem (pons or medulla)
    • Midbrain (mesencephalon)
    • Primary sensorimotor cortex in the dominant hemisphere
    • Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve

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 and 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 OR
  • BUN no greater than 30 mg/dL

Other:

  • No active uncontrolled infection
  • Afebrile (37.5 degrees C) unless fever due to tumor
  • No other unstable or severe medical condition
  • No complicating medical or psychiatric problem that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas, mitomycin, or Gliadel wafers) and recovered
  • No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy and recovered
  • No prior intracranial brachytherapy
  • No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume increases by more than 25% by MRI

Surgery:

  • See Disease Characteristics
  • Prior surgery allowed
  • No anti-tumor surgery within 12 weeks after study drug

Other:

  • No concurrent anticoagulants
  • No other concurrent investigational agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Direct Therapeutics

Investigators

  • Study Chair: Gene David Resnick, MD, Millennix

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Registration Dates

First Submitted

February 2, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

March 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068416
  • DTI-0002
  • UCSF-H7858-17520-01
  • NCI-V00-1642

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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