Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peregrine Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00677716
First received: May 12, 2008
Last updated: February 2, 2012
Last verified: February 2012

May 12, 2008
February 2, 2012
July 2007
September 2011   (final data collection date for primary outcome measure)
To confirm the safety and tolerability of the maximum tolerated dose [ Time Frame: Unknown ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00677716 on ClinicalTrials.gov Archive Site
To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment. [ Time Frame: Unknown ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse

Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out". This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.

To confirm the safety and tolerability of the Maximum Tolerated Dose (MTD) of 131I-chTNT-1/B MAb given as a single interstitial infusion in patients with glioblastoma multiforme at first relapse.

To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glioblastoma Multiforme
Drug: 131I-chTNT-1/B MAb (Cotara)
Given as a single interstitial infusion over approximately 25 hours at a dose of 2.5 mCi/cc.
Other Name: Cotara®
Experimental: 131I-chTNT-1/B MAb (Cotara)
Intervention: Drug: 131I-chTNT-1/B MAb (Cotara)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
November 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed GBM
  • Clinical Target Volume between 5 and 60 cc (inclusive)
  • 18 to 75 years old (inclusive)
  • Karnofsky Performance Status ≥ 70 percent
  • If on steroids dose (± 4mg/day) must be stable for at least two weeks prior to screening/baseline visit. If not on steroids for two weeks prior to screening/baseline visit are allowed
  • Adequate hematology
  • Adequate renal function
  • Adequate liver function

Exclusion Criteria:

  • Infratentorial tumor(s), tumor(s) that communicate with the ventricles or intraventricular disease
  • Bilateral non-contiguous gadolinium enhancing tumor
  • Diffuse disease (i.e., any satellite lesions less than 1.5 cm from anticipated location of any catheter tip or less than two satellite lesions)
  • Known or suspected allergy to study medication or iodine
  • Surgical procedure within four weeks of baseline
  • More than one prior chemotherapy regime or chemotherapy within four weeks (nitrosourea-based within six weeks) of baseline
  • Radiation therapy within four weeks of baseline
  • Investigational agent within last 30 days
  • Previous treatment with any chimeric monoclonal antibody
  • HIV positive
  • Evidence of active hepatitis
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India
 
NCT00677716
PPHM 0503
No
Peregrine Pharmaceuticals
Peregrine Pharmaceuticals
Not Provided
Principal Investigator: Deepak K Gupta, MBBS,MS,MCh All India Institute of Medical Sciences, New Delhi
Peregrine Pharmaceuticals
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP