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Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study


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

Thank you

Trial Information

Interstitial Infusion of IL 13-PE38QQR Cytotoxin in Recurrent Malignant Glioma: Phase I/II Study


OBJECTIVES:

- Determine the toxic effects and maximum tolerated dose (MTD) of interstitial
interleukin-13 PE38QQR immunotoxin in patients with malignant glioma.

- Determine the response rate, duration of response, time to response, overall survival,
and time to progression in patients treated with this regimen.

- Determine the toxic effects of this drug at the MTD in these patients.

OUTLINE: This is a dose-escalation, multicenter study.

Patients undergo stereotactic biopsy of brain tumor followed by CT guided stereotactic
placement of 2 intratumoral catheters on day 0. Patients with histologically confirmed
malignant glioma receive interleukin-13 PE38QQR immunotoxin interstitially over 96 hours
beginning on day 1. Patients with a residual enhancing mass undergo repeat catheter
placement on day 56 and then receive a second interstitial infusion beginning on day 57 in
the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of interleukin-13 PE38QQR immunotoxin until
the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of
6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for phase I of the study within
6 months and a total of 12-35 patients will be accrued for phase II of the study within
10-12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven malignant glioma (grade 3 or 4)

- Anaplastic astrocytoma

- Glioblastoma multiforme

- Malignant mixed oligoastrocytoma

- Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at
least 12 weeks prior to study

- Must have undergone supratentorial brain tumor surgery or biopsy

- Must have radiographic evidence of recurrent or progressive supratentorial tumor
compared with prior study

- Must have solid portion measuring 1.0-5.0 cm in maximum diameter

- Maximum of 1 satellite lesion allowed if separated from the primary mass by less
than 3 cm

- No tumor crossing the midline

- No leptomeningeal tumor dissemination

- No impending herniation or spinal cord compression

- No uncontrolled seizures

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

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

- Hemoglobin at least 10 g/dL

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

Hepatic:

- PT and PTT no greater than upper limit of normal (ULN)

- SGOT and SGPT no greater than 2.5 times ULN

- Bilirubin no greater than 2.0 mg/dL

Renal:

- Not specified

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior intralesional chemotherapy for malignant glioma

- At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas)
and recovered

- No concurrent chemotherapy

Endocrine therapy:

- Concurrent corticosteroids allowed, but dose must remain stable or be tapered during
study

Radiotherapy:

- See Disease Characteristics

- No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or
brachytherapy) for malignant glioma

Surgery:

- See Disease Characteristics

Other:

- Recovered from any prior therapy

- No other concurrent investigational agent

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jon Weingart, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068211

NCT ID:

NCT00006268

Start Date:

October 2000

Completion Date:

March 2005

Related Keywords:

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

Name

Location

University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Abramson Cancer Center at the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
Josephine Ford Cancer Center at Henry Ford Health SystemDetroit, Michigan  48202
Warren Grant Magnuson Clinical Center - NCI Clinical Studies SupportBethesda, Maryland  20892-1182
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
National Institute of Neurological Disorders and StrokeBethesda, Maryland  20892-1414