Radiolabeled Monoclonal Antibody in Treating Patients With Glioblastoma Multiforme or Anaplastic Astrocytoma - Full Text View

Sponsored by:	Peregrine Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004017

Purpose

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.

Condition	Intervention	Phase
Brain and Central Nervous System Tumors	Procedure: conventional surgery Radiation: iodine I 131 monoclonal antibody TNT-1/B	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Immunoglobulins Iodine Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
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

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	60
Study Start Date:	February 2000

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004017

Locations

United States, North Carolina
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States, 28207-1830
United States, Pennsylvania
Temple University
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

Peregrine Pharmaceuticals

Investigators

Study Chair:

Terrence G. Chew, MD

Peregrine Pharmaceuticals

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067235, PEREGRINE-TNT9802, MUSC-7993, PEREGRINE-BB-IND-7344, TCLONE-BB-IND-7344, TCLONE-TNT9802, NCI-G99-1560
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004017 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent adult brain tumor
adult glioblastoma
adult anaplastic astrocytoma
adult giant cell glioblastoma
adult gliosarcoma

Study placed in the following topic categories:

Glioblastoma
Immunologic Factors
Astrocytoma
Central Nervous System Neoplasms
Recurrence
Antibodies, Monoclonal
Brain Neoplasms
Neuroectodermal Tumors
Antibodies

Neoplasms, Germ Cell and Embryonal
Iodine
Neuroepithelioma
Glioma
Glioblastoma Multiforme
Gliosarcoma
Nervous System Neoplasms
Immunoglobulins
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Neoplasms by Histologic Type
Immunologic Factors
Astrocytoma
Physiological Effects of Drugs
Nervous System Diseases
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Pharmacologic Actions
Antibodies, Monoclonal

Neuroectodermal Tumors
Antibodies
Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009