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Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003876
Recruitment Status : Completed
First Posted : May 20, 2004
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

November 1, 1999
May 20, 2004
June 26, 2013
April 1999
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Complete list of historical versions of study NCT00003876 on Archive Site
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Internal Radiation Therapy Plus Carmustine Implants in Treating Patients With Recurrent or Refractory Malignant Glioma
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

RATIONALE: Internal radiation uses high-energy radiation to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining internal radiation therapy with chemotherapy implants may kill remaining tumor cells following surgery.

PURPOSE: Phase I trial to study the effectiveness of internal radiation therapy plus carmustine implants in treating patients who have recurrent or refractory malignant glioma.

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 death.

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

Phase 1
Primary Purpose: Treatment
Brain and Central Nervous System Tumors
  • Drug: polifeprosan 20 with carmustine implant
  • Procedure: surgical procedure
  • Radiation: iodine I 125
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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May 2004
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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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000067042 ( Registry Identifier: PDQ (Physician Data Query) )
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Barrett Cancer Center
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Study Chair: Robert E. Albright, MD Barrett Cancer Center
National Cancer Institute (NCI)
May 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP