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A Phase I Study of Concurrent Multi-modality Treatment for Patients With Relapsed Malignant Glioma Using Permanent I-125 Interstitial Seeds and Dose Escalation of Gliadel 3.85% Carmustine (BCNU) Polymer Wafers

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

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Trial Information

A Phase I Study of Concurrent Multi-modality Treatment for Patients With Relapsed Malignant Glioma Using Permanent I-125 Interstitial Seeds and Dose Escalation of Gliadel 3.85% Carmustine (BCNU) Polymer Wafers

OBJECTIVES: I. Assess the toxic effects of concurrent permanent iodine I 125 interstitial
seed implants and polifeprosan 20 with carmustine implant (Gliadel wafers) in patients with
recurrent or refractory malignant glioma. II. Assess preliminary efficacy of this regimen in
terms of progression free survival and overall survival of these patients. III. Assess
impact of this regimen on the quality of life and performance status of these patients. IV.
Assess site of tumor progression following this regimen in these patients. V. Assess the
relationship between progression free survival and the MIB-1 proliferative index of the
resected malignant glioma.

OUTLINE: This is a dose escalation study. Patients undergo craniotomy with the intent to
obtain a complete resection of enhancing tumor. Following maximum tumor removal, iodine I
125 seeds and up to 8 polifeprosan 20 with carmustine implants (Gliadel wafers) are
implanted into the resected tumor cavity. Cohorts of 6 patients each receive increasing
numbers of Gliadel wafers placed into the tumor cavity. Quality of life is assessed at
baseline, then every 3 months, and at tumor progression. Patients are followed monthly until

PROJECTED ACCRUAL: A total of 12-18 patients will be accrued for this study within 18

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory glioblastoma
multiforme, gliosarcoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic
oligoastrocytoma (mixed glioma), anaplastic pleomorphic xanthoastrocytoma, or malignant
dedifferentiation from prior low grade glioma Tumor in first relapse Measurable disease by
MRI scan Enhancing lesion amenable to gross total resection Postoperative resection cavity
not communicating freely with ventricular system

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Greater than 8 weeks Hematopoietic: Absolute neutrophil count greater than
1,000/mm3 Hemoglobin greater than 10.0 g/dL Platelet count greater than 100,000/mm3
Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT or SGPT less than
2.5 times ULN Renal: Not specified Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception HIV negative No AIDS-related illness No
other malignancy within past 5 years, except: Basal or squamous cell carcinoma of the skin
Carcinoma in situ of the cervix No psychological, familial, sociological, or geographical
conditions that would interfere with study compliance No active infection requiring
systemic antibiotics No nonmalignant systemic disease considered to increase medical risk

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas or mitomycin) and
recovered No prior polifeprosan 20 with carmustine implant (Gliadel wafers) Prior adjuvant
chemotherapy allowed No other concurrent chemotherapy Endocrine therapy: Patient on stable
steroid therapy for at least 2 weeks prior to study No concurrent hormonal agents
Radiotherapy: Prior radiosensitization allowed and recovered Prior external beam
radiotherapy required and recovered No concurrent radiotherapy (including palliative)
Surgery: Prior surgery or biopsy required and recovered Other: No prior iodine I 125 seed
implants Concurrent alternative therapy allowed No other concurrent antineoplastic therapy
No other concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Robert E. Albright, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Barrett Cancer Center


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

May 2004

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult brain stem glioma
  • 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



Barrett Cancer Center, The University Hospital Cincinnati, Ohio  45219