|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00677716 |
|
Date of registration:
|
12/05/2008 |
|
Primary sponsor: |
|
|
Public title:
|
Dose Confirmation Study of Cotara for the Treatment of Glioblastoma Multiforme at First Relapse
|
|
Scientific title:
|
Open-label, Dose Confirmation Study of Interstitial 131I-chTNT-1/B MAb (Cotara®) for the Treatment of Glioblastoma Multiforme (GBM) at First Relapse |
|
Date of first enrolment:
|
July 2007 |
|
Target sample size:
|
41 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00677716 |
|
Study type:
|
Interventional |
|
Study design:
|
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
India
|
United States
| | | | | | |
|
Contacts
|
|
Name:
|
Deepak K Gupta, MBBS,MS,MCh |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
All India Institute of Medical Sciences, New Delhi |
| | |
|
Key inclusion & exclusion criteria
|
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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Glioblastoma Multiforme
|
|
Intervention(s)
|
|
Drug: 131I-chTNT-1/B MAb (Cotara)
|
|
Primary Outcome(s)
|
|
To confirm the safety and tolerability of the maximum tolerated dose
[Time Frame: Unknown]
|
|
Secondary Outcome(s)
|
|
To estimate overall survival, progression free survival and proportion of patients alive at six months after treatment.
[Time Frame: Unknown]
|
|
Secondary ID(s)
|
|
PPHM 0503
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|