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Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)


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

Thank you

Trial Information

Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)


OBJECTIVES:

- Define the maximum tolerated dose of irinotecan given in combination with Gliadel
wafers (carmustine) in patients with recurrent glioblastoma multiforme, anaplastic
astrocytoma, or gliosarcoma.

- Define the toxicity of irinotecan given in combination with Gliadel wafers in these
patients.

OUTLINE: This is a dose escalation study.

All patients undergo surgical resection. At the time of surgery, up to eight Gliadel wafers
(containing carmustine) are implanted in the resected tumor cavity.

Cohorts of 3 patients each receive escalating doses of irinotecan IV over 90 minutes once
weekly within 3 weeks after Gliadel wafer implantation. One course of treatment consists of
4 weeks of irinotecan and 2 weeks of rest. If 1 patient experiences dose limiting toxicity
(DLT) at a dose level, an additional 3 patients are entered at that same dose level. If 2
patients experience DLT, the maximum tolerated dose (MTD) has been surpassed and a total of
6 patients are treated at the previous dose level. The MTD is defined as the highest dose in
which no more than 1 of 6 patients experiences DLT.

Treatment continues for up to 12 courses in the absence of unacceptable toxicity and disease
progression.

Patients are followed for at least 4 months.

PROJECTED ACCRUAL: Approximately 18 patients will be accrued into this study over 9 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent supratentorial glioblastoma multiforme, anaplastic
astrocytoma, or gliosarcoma

- Must be able to undergo surgical resection

- At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours
after surgical implantation of Gliadel wafers

- Not requiring immediate radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- Greater than 12 weeks

Hematopoietic:

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

- Platelet count at least 125,000/mm^3

- Hematocrit at least 29%

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT or SGPT less than 2.5 times ULN

- Alkaline phosphatase less than 2 times ULN

Renal:

- BUN less than 1.5 times ULN

- Creatinine less than 1.5 times ULN

Neurological:

- Must be neurologically stable

Other:

- HIV negative

- No AIDS-related illness

- No nonmalignant systemic disease that would make patient a poor medical risk

- No acute infection requiring intravenous antibiotics

- Not pregnant or nursing

- Negative pregnancy test 24 hours prior to study

- Effective contraception required of all fertile patients

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior irinotecan

- At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor
progression after chemotherapy

Endocrine therapy:

- At least 1 week of nonincreasing dose of steroids prior to study

Radiotherapy:

- At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor
progression after radiotherapy

- No concurrent radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

0901

NCT ID:

NCT00003463

Start Date:

July 1998

Completion Date:

July 2002

Related Keywords:

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

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Duke Comprehensive Cancer CenterDurham, North Carolina  27710