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A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma

Phase 1/Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

A Phase I/II Study of Col-3 Administered on a Continuous Daily Oral Schedule in Patients With Recurrent High-Grade Astrocytoma


- Determine the maximum tolerated dose, dose limiting toxicity, and safety profile of
oral COL-3 alone or when combined with anticonvulsants known to be metabolized by
CYP450 in patients with progressive or recurrent high grade anaplastic astrocytoma,
anaplastic oligodendroglioma, or glioblastoma multiforme.

- Define the pharmacokinetics and pharmacodynamics of COL-3 on this schedule and
determine the effects of hepatic enzyme inducing drugs, such as anticonvulsants, on the

- Determine the response rate, disease free survival, and survival in patients treated
with this regimen.

OUTLINE: This is a dose-escalation, multicenter study of COL-3. Patients are stratified by
anticonvulsant (anticonvulsants that cause induction of CYP450 vs anticonvulsants that cause
modest or no induction of CYP450 or no anticonvulsant).

- Phase I: Patients receive oral COL-3 daily. Treatment repeats every 4 weeks in the
absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of COL-3 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity.

- Phase II: Patients receive oral COL-3 daily at the MTD from the phase I portion of this

Patients are followed every 2 months until death.

PROJECTED ACCRUAL: A total of 15-18 patients will be accrued for phase I of the study and a
total of 35 patients will be accrued for phase II of the study at a rate of 3 patients per

Inclusion Criteria


- Histologically proven high grade glioma that is progressive or recurrent following
radiotherapy or chemotherapy

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Glioblastoma multiforme

- Prior low grade glioma that has progressed to high grade glioma following
radiotherapy and/or chemotherapy allowed

- Measurable disease by MRI or CT scan



- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin normal

- SGOT or SGPT no greater than 2.5 times upper limit of normal


- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance greater than 60 mL/min


- No myocardial infarction, stroke, or congestive heart failure within the past 3


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study

- No serious active infection or medical illness that would preclude compliance

- HIV negative

- No history of gastrointestinal disorders that would interfere with absorption of
study drug

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

- No hypersensitivity to tetracyclines or its derivatives


Biologic therapy:

- No concurrent filgrastim (G-CSF)


- At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas) and

- No more than 2 prior chemotherapy regimens

Endocrine therapy:

- Not specified


- No prior large field radiotherapy (greater than 20% of total bone marrow)

- At least 3 months since other prior radiotherapy and recovered


- No prior major upper gastrointestinal surgery

- At least 14 days since other prior major surgery


- No other concurrent investigational agents

- No prolonged sun exposure

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Pamela Z. New, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Texas Health Science Center at San Antonio


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

November 2006

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
  • Astrocytoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Emory University Hospital - Atlanta Atlanta, Georgia  30322
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Henry Ford Hospital Detroit, Michigan  48202
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410