Know Cancer

or
forgot password

Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)


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 Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)


OBJECTIVES:

- Determine the maximum tolerated dose of irinotecan administered in combination with
temozolomide in patients with recurrent primary malignant glioma.

- Determine the toxicity of this combination therapy in these patients.

OUTLINE: This is a dose escalation study of irinotecan. Patients are stratified according to
concurrent anticonvulsants (Dilantin, Tegretol, or phenobarbital vs other anticonvulsants or
none).

Patients receive irinotecan IV over 90 minutes on days 1, 8, 15, and 22 and oral
temozolomide on days 1-5. Treatment continues every 43 days in the absence of disease
progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of irinotecan 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 toxicities.

PROJECTED ACCRUAL: Not specified

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent primary malignant glioma

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Anaplastic oligodendroglioma

- Gliosarcoma

- Anaplastic mixed oligoastrocytoma

- Measurable disease by MRI or CT

- No immediate radiotherapy required

- Neurologically stable for at least 2 weeks prior to study

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Greater than 12 weeks

Hematopoietic:

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

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

- Hemoglobin at least 10 g/dL

Hepatic:

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

- SGOT and SGPT less than 2.5 times ULN

- Alkaline phosphatase less than 2 times ULN

Renal:

- Blood urea nitrogen and creatinine less than 1.5 times ULN

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No other nonmalignant systemic disease

- No acute infection treated with IV antibiotics

- No frequent vomiting or other condition that would preclude oral medication
administration (e.g., partial bowel obstruction)

- No other prior malignancies except surgically cured carcinoma in situ of the cervix
or basal or squamous cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No more than 1 prior biologic therapy regimen

Chemotherapy:

- No more than 1 prior chemotherapy regimen

- At least 6 weeks since prior chemotherapy, unless evidence of disease progression

- No prior failure of irinotecan or temozolomide

Endocrine therapy:

- Concurrent corticosteroids allowed

Radiotherapy:

- See Disease Characteristics

- At least 6 weeks since prior radiotherapy, unless evidence of disease progression

Surgery:

- At least 3 weeks since prior surgery, unless evidence of disease progression, and
recovered

Other:

- No concurrent immunosuppressive agents

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:

1087 (CDR0000067931)

NCT ID:

NCT00005951

Start Date:

August 2000

Completion Date:

April 2006

Related Keywords:

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

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710