Open Label Clinical Trial of Intravenous Crotoxin
The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus administration.
Crotoxin has been shown to induce neurotoxic tolerance in animals allowing them to receive high doses associated with effective anti-tumor activity in the absence of adverse side effects.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open Label Phase I Clinical Trial of Crotoxin in Patients With Advanced Cancer Using an Intravenous Route of Administration|
- Tolerability of intra-patient dose escalation [ Time Frame: 54 days ] [ Designated as safety issue: Yes ]Assess the safety and tolerability of Crotoxin administered intravenously to Stage IV cancer patients using intra-patient dose escalation procedure.
- Confirmation of the induction of drug tolerance [ Time Frame: 54 days ] [ Designated as safety issue: Yes ]Confirm in a controlled phase I trial that human subjects can be made tolerant to intravenously administered Crotoxin thereby reducing the potential for adverse drug effects
- Assessment of drug efficacy [ Time Frame: 54 days ] [ Designated as safety issue: No ]Document any objective anti-tumour responses that occur in patients treated on this protocol.
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
|Contact: Dorothy Bray, Ph.D.||+firstname.lastname@example.org|
|Hôpital Européen Georges Pompidou||Recruiting|
|Paris, France, 75908|
|Contact: Jacques Medioni, MD + 33 (1) 56 09 27 81 email@example.com|
|Principal Investigator: Jacques Medioni, MD|
|Principal Investigator:||Jacques Medioni, MD||Hôpital Européen Georges Pompidou Paris, France|