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Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse


Phase 2
18 Years
75 Years
Not Enrolling
Both
Glioblastoma Multiforme

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Trial Information

Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To confirm the safety and tolerability of the maximum tolerated dose

Outcome Time Frame:

Unknown

Safety Issue:

Yes

Principal Investigator

Deepak K Gupta, MBBS,MS,MCh

Investigator Role:

Principal Investigator

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi

Authority:

India: Drugs Controller General of India

Study ID:

PPHM 0503

NCT ID:

NCT00677716

Start Date:

July 2007

Completion Date:

November 2011

Related Keywords:

  • Glioblastoma Multiforme
  • glioblastoma multiforme
  • GBM
  • brain cancer
  • Cotara
  • radioactive isotope
  • monoclonal antibody
  • Glioblastoma multiforme at first relapse
  • Glioblastoma

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Barrow Neurological InstitutePhoenix, Arizona  85013
University of Pennsylvania, Department of NeurosurgeryPhiladelphia, Pennsylvania  19104