Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004017
• Other study ID #: CDR0000067235
• Secondary ID: PEREGRINE-TNT980
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: February 6, 2009
• Start date: February 2000

Study information

• Verified date: March 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. This may be an effective treatment for some types of brain tumors.

PURPOSE: Phase II trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients who have glioblastoma multiforme or anaplastic astrocytoma.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Nervous System Neoplasms

Intervention

Procedure:
• conventional surgery

Radiation:
• iodine I 131 monoclonal antibody TNT-1/B

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Carolina Neurosurgery and Spine Associates	Charlotte	North Carolina
United States	Temple University	Philadelphia	Pennsylvania
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Peregrine Pharmaceuticals

Country where clinical trial is conducted

United States,