Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma
OBJECTIVES:
- Determine the median time to disease progression in patients with newly diagnosed
unresectable glioblastoma multiforme (GBM), recurrent GBM, or recurrent anaplastic
astrocytoma treated with interstitial iodine I 131 monoclonal antibody TNT-1/B.
- Determine the median survival time of these patients treated with this regimen.
- Determine the safety of this regimen in terms of neurotoxicity, renal, hepatic,
hematologic, and biochemical profiles in these patients.
- Confirm the maximum tolerated dose of this regimen in these patients.
- Optimize the drug delivery of this regimen in these patients.
- Assess the response of these patients in terms of MRI measured gadolinium enhanced
tumor volume and gadolinium enhanced tumor area at 8 and 12 weeks following the last
dose of study drug.
OUTLINE: This is a multicenter study.
Patients undergo stereotactic implantation of 2 interstitial catheters into the tumor bed.
One day later, patients receive iodine I 131 monoclonal antibody TNT-1/B interstitially over
approximately 24 hours. At selected centers, up to 3 additional groups of 3 patients each
will receive study drug up to 48 hours. Catheters are removed 1 day after completion of the
infusion. A gadolinium enhanced MRI is performed during week 8. Patients with partial
response, minimal response, or stable disease repeat the above treatments during week 9.
Patients with complete response, progressive disease, or unacceptable toxicity receive no
additional treatment.
Patients are followed every month until disease progression. All patients regardless of
disease progression or retreatment are followed at 36 weeks.
PROJECTED ACCRUAL: A total of 60 patients (20 patients with newly diagnosed unresectable
glioblastoma multiforme [GBM]; 20 patients with recurrent GBM; and 20 patients with
recurrent anaplastic astrocytoma) will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed newly diagnosed unresectable glioblastoma multiforme (GBM),
recurrent GBM, or recurrent anaplastic astrocytoma (AA)
- MRI scan documenting gadolinium enhanced tumor volume of at least 5 cm3, but no
greater than 60 cm^3
- Recurrent GBM and AA must be documented by MRI after the most recent treatment
and before any planned surgical debulking
- At least 5 days since prior surgical debulking
- No planned resection of newly diagnosed GBM before or during study
- No bilateral noncontiguous gadolinium enhancing tumors
- No satellite lesions greater than 1.5 cm from anticipated location of interstitial
catheter tip
- No more than 2 satellite lesions
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- Platelet count at least 100,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- WBC at least 3,000/mm^3
Hepatic:
- Hepatitis B surface antigen negative
- Bilirubin no greater than 2.5 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
- Lactic dehydrogenase no greater than 3 times ULN
- Prothrombin time no greater than 1.5 times ULN
Renal:
- Creatinine clearance at least 50 mL/min
Cardiovascular:
- No significant unstable cardiovascular disease
- No New York Heart Association class III/IV heart disease
- No evidence of myocardial infarction within the past 3 months
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Human antichimeric antibody (HACA) titer no greater than 48 ng/mL
- No anatomical or physiological considerations that would preclude study participation
- No active autoimmune disease, active infection, or traumatic injury requiring
treatment
- HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 4 weeks since prior intravenous chemotherapy or Gliadel wafers
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 8 weeks since prior external beam or gamma knife radiotherapy
Surgery:
- See Disease Characteristics
Other:
- At least 30 days since prior investigational treatment
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Terrence G. Chew, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Peregrine Pharmaceuticals
Authority:
United States: Federal Government
Study ID:
CDR0000067235
NCT ID:
NCT00004017
Start Date:
February 2000
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- recurrent adult brain tumor
- adult glioblastoma
- adult anaplastic astrocytoma
- adult giant cell glioblastoma
- adult gliosarcoma
- Astrocytoma
- Glioblastoma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
Name | Location |
|---|---|
| Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
| Huntsman Cancer Institute | Salt Lake City, Utah 84112 |
| Carolina Neurosurgery and Spine Associates | Charlotte, North Carolina 28207-1830 |
| Temple University | Philadelphia, Pennsylvania 19140 |
