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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.)

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Gene David Resnick, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Millennix

Authority:

United States: Federal Government

Study ID:

CDR0000068207

NCT ID:

NCT00006656

Start Date:

June 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Medical College of WisconsinMilwaukee, Wisconsin  53226
John F. Kennedy Medical CenterEdison, New Jersey  08818
Massey Cancer CenterRichmond, Virginia  23298-0037
Evanston Northwestern Health CareEvanston, Illinois  60201
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Barrett Cancer CenterCincinnati, Ohio  45267-0502