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Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas


OBJECTIVES:

- Determine the maximum tolerated dose of karenitecin in patients with recurrent
malignant glioma who are receiving or not receiving anticonvulsants known to be
metabolized by the P450 hepatic enzyme complex.

- Determine the pharmacokinetics of this drug in these patients.

- Assess the preliminary evidence of therapeutic activity of this drug in these patients.

OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to
use of anticonvulsants known to be metabolized by the P450 hepatic enzyme complex (yes vs
no).

Patients receive karenitecin IV over 60 minutes on days 1-5. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of karenitecin according to the continual
reassessment method until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose associated with a dose-limiting toxicity rate of 33%.

Patients are followed every 2 months.

PROJECTED ACCRUAL: Approximately 3-24 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, or
glioblastoma multiforme

- Progressive or recurrent disease previously treated with radiotherapy with or without
chemotherapy

- Prior low-grade disease that progressed to high-grade after therapy allowed

- Measurable disease by 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

- Platelet count at least 100,000/mm3

- Hemoglobin at least 8.5 g/dL

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

- Transaminases no greater than 4 times upper limit of normal

Renal:

- Creatinine no greater than 1.7 mg/dL

Other:

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix or breast

- No serious concurrent infection

- No other medical illness that would preclude study

- Negative pregnancy test

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No more than 1 prior chemotherapy regimen

Endocrine therapy:

- Must be on stable dose of steroids for at least 5 days

Radiotherapy:

- See Disease Characteristics

- At least 3 months since prior radiotherapy and recovered

- No more than 1 prior course of radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational agents

- At least 10 days since prior anticonvulsant drugs that induce hepatic metabolic
enzymes

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068552

NCT ID:

NCT00014521

Start Date:

January 2002

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202