Know Cancer

or
forgot password

Phase II Open-Label, Non-Randomized, Multicenter Study of Interstitial 131I-chTNT-1/B for the Treatment of Newly Diagnosed or Recurrent Malignant Glioma


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

Thank you

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 CarolinaCharleston, South Carolina  29425-0721
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Carolina Neurosurgery and Spine AssociatesCharlotte, North Carolina  28207-1830
Temple UniversityPhiladelphia, Pennsylvania  19140