Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Karenitecin in Treating Patients With Recurrent Malignant Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	18 and over	NCI	NABTT-2006 JHOC-NABTT-2006, NCT00014521

Objectives

1. 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.
2. Determine the pharmacokinetics of this drug in these patients.
3. Assess the preliminary evidence of therapeutic activity of this drug in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• 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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

New Approaches to Brain Tumor Therapy

Stuart Grossman, MD, Protocol chair		Ph: 410-955-8837 Email: Grossman@jhmi.edu

Registry Information
Official Title		Phase I Evaluation Of The Safety Of Karenitecin In The Treatment Of Recurrent Malignant Gliomas
Trial Start Date		2002-01-08
Registered in ClinicalTrials.gov		NCT00014521
Date Submitted to PDQ		2001-02-16
Information Last Verified		2005-02-04
NCI Grant/Contract Number		CA006973, CA062475

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