Open Label Clinical Trial of Intravenous Crotoxin
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|ClinicalTrials.gov Identifier: NCT01481532|
Recruitment Status : Recruiting
First Posted : November 29, 2011
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Crotoxin||Phase 1|
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.
The study plans to demonstrate this effect in human subjects using two dose escalation protocols; slow and fast. It is believed that this approach will prevent toxic side effects to subjects.
The route of administration has not been employed clinically and is designed to avoid the myonecrotic effects of intramuscular injections. The target maximum dose is almost double that off the previously reported MTD.
The revised protocol incorporates continuous infusion with a mobile pump and includes active suppression of the allergic reaction by pre-treatment administration of antihistamines.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Phase I Clinical Trial of Crotoxin in Patients With Advanced Cancer Using an Intravenous Route of Administration|
|Anticipated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||February 2019|
Experimental: Cohort 3
The third cohort will include up to 18 patients with Crotoxin doses of 0.12 to 1.16 mg per m2 in which the dose escalation speed will be faster. Drug is administered over 48 hour intervals using ambulatory infusion pumps; treating on an outpatient basis. Subjects will receive increasing doses over the course of 35 treatment days (15 dose levels).
Intra patient dose escalation
Other Name: antihistamine
- Tolerability of intra-patient dose escalation [ Time Frame: 35 days ]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: 35 days ]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: 35 days ]Document any objective anti-tumour responses that occur in patients treated on this protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481532
|Contact: Dorothy Bray, Ph.D.||+firstname.lastname@example.org|
|Paris, France, 75013|
|Contact: Maria A Gil-Delgado, MD +33 1 42 16 05 08 email@example.com|
|Principal Investigator: Maria A Gil-Delgado, MD|
|Principal Investigator:||Maria A Gil-Delgado, MD, Ph.D||Salpetriere Hospital, Paris, France|