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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00004017
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Peregrine Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Terrence G. Chew, MD
Principal Investigator Affiliation Peregrine Pharmaceuticals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Charlotte, North Carolina

Status

Address

Carolina Neurosurgery and Spine Associates

Charlotte, North Carolina, 28207-1830

Temple University, Philadelphia, Pennsylvania

Status

Address

Temple University

Philadelphia, Pennsylvania, 19140

Medical University of South Carolina, Charleston, South Carolina

Status

Address

Medical University of South Carolina

Charleston, South Carolina, 29425-0721

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

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