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A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas


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

Thank you

Trial Information

A Phase I Trial Of CC-8490 For The Treatment Of Patients With Recurrent/Refractory High-Grade Gliomas


OBJECTIVES:

Primary

- Determine the maximum tolerated dose of CC-8490 in patients with recurrent or
refractory high-grade gliomas.

- Determine, preliminarily, the toxic effects of this drug in these patients.

- Determine the pharmacokinetics of this drug in these patients.

Secondary

- Determine, preliminarily, the potential anti-glioma activity of this drug in these
patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral CC-8490 once daily on days 1 and 3-28 (course 1 only). Beginning with
course 2 and for all subsequent courses, patients receive oral CC-8490 once daily on days
1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease
progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CC-8490 until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
patients experience dose-limiting toxicity. Once the MTD is determined, a total of 10
patients are treated at that dose.

Patients are followed within 2 weeks.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed supratentorial malignant glioma, including any of the
following:

- Glioblastoma multiforme

- Gliosarcoma

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma

- Anaplastic mixed oligoastrocytoma

- Malignant glioma/astrocytoma not otherwise specified OR

- Clinical and radiographic diagnosis of progressive low-grade glioma

- Radiographically diagnosed infiltrating brain stem gliomas not amenable to biopsy
allowed

- Recurrent or progressive disease as determined by 1 of the following:

- CT scan or MRI within the past 21 days

- Biopsy within the past 12 weeks

- Failed prior radiotherapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 60-100%

Life expectancy

- More than 8 weeks

Hematopoietic

- Granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3 (transfusion independent)

- Hemoglobin at least 8 g/dL (transfusion allowed)

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- AST and ALT no greater than 2 times upper limit of normal

- No significant active hepatic disease that would preclude study participation

Renal

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

- No significant active renal disease that would preclude study participation

Cardiovascular

- No significant active cardiac disease that would preclude study participation

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

- No other malignancy within the past 3 years except nonmelanoma skin cancer or
carcinoma in situ of the cervix

- No significant active psychiatric disease that would preclude study participation

- No other condition or laboratory abnormality that would preclude study participation

- Able to swallow capsules whole

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 2 weeks since prior interferon

- No concurrent immunotherapy

Chemotherapy

- At least 2 weeks since prior vincristine

- At least 3 weeks since prior procarbazine

- At least 4 weeks since prior temozolomide or carboplatin

- At least 6 weeks since prior nitrosoureas

- No other concurrent anticancer chemotherapy

Endocrine therapy

- At least 2 weeks since prior tamoxifen

- Concurrent steroids allowed provided dose has been stable for at least 5 days prior
to study enrollment

Radiotherapy

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery

- At least 2 weeks since prior resection of a recurrent or progressive tumor

Other

- At least 2 weeks since other prior non-cytotoxic therapy

- At least 4 weeks since other prior cytotoxic therapies

- More than 28 days since prior experimental study drugs

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard A. Fine, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI - Neuro-Oncology Branch

Authority:

United States: Federal Government

Study ID:

CDR0000343702

NCT ID:

NCT00074243

Start Date:

December 2003

Completion Date:

Related Keywords:

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

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182