Ignite Creation Date:
2024-05-05 @ 10:59 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01222780
Status:
COMPLETED
Last Update Posted:
2020-01-18
First Post:
2010-10-15
Brief Title:
To Evaluate the Safety Activity and Pharmacokinetics of Marqibo in Children and Adolescents With Refractory Cancer
Sponsor:
Acrotech Biopharma Inc
Organization:
Acrotech Biopharma Inc
Study Overview
Official Title:
Phase I Trial to Evaluate the Safety Activity and Pharmacokinetics of MarqiboRegistered Trademark Vincristine Sulfate Liposomes Injection in Children and Adolescents With Refractory Cancer
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
MarqiboRegistered Trademark is a new anticancer drug It combines Vincristine sulfate which is a widely used anticancer drug and packages it into a tiny fat bubble known as a liposome The goal of this is to improve the drugs ability to destroy cancer cells and help reduce the potential side effects of treatment
Vincristine sulfate was originally developed from chemicals found in the periwinkle plant and acts against multiple types of malignant cancer It is approved for multiple cancer types including solid tumors and blood cancers
Research has shown that MarqiboRegistered Trademark is able to slow or stop the growth of cancer cells in some adults both alone and in combination with other chemotherapy drugs but more research is needed to determine its use in children
There has been one previous small study of MarqiboRegistered Trademark in children Although some anti-cancer activity was seen side effects and optimal dosing were not fully determined
As is seen with standard Vincristine suflate the most common side effect of MarqiboRegistered Trademark involves the nervous system It can cause numbness and tingling in the hands and feet Symptoms commonly improve when the drug is discontinued or the dose is lowered
Objectives
- To determine the safety and efficacy of Marqibo as a treatment for children who have been diagnosed with certain types of malignant cancer that has not responded to standard treatment
Eligibility
Children and adolescents between 2 and 21 years of age who have been diagnosed with certain types of malignant cancer that has not responded to standard treatment
These cancer types include solids tumors primary brain tumors leukemias and lymphomas
MarqiboRegistered Trademark is a new anticancer drug It combines Vincristine sulfate which is a widely used anticancer drug and packages it into a tiny fat bubble known as a liposome The goal of this is to improve the drugs ability to destroy cancer cells and help reduce the potential side effects of treatment
Vincristine sulfate was originally developed from chemicals found in the periwinkle plant and acts against multiple types of malignant cancer It is approved for multiple cancer types including solid tumors and blood cancers
Research has shown that MarqiboRegistered Trademark is able to slow or stop the growth of cancer cells in some adults both alone and in combination with other chemotherapy drugs but more research is needed to determine its use in children
There has been one previous small study of MarqiboRegistered Trademark in children Although some anti-cancer activity was seen side effects and optimal dosing were not fully determined
As is seen with standard Vincristine suflate the most common side effect of MarqiboRegistered Trademark involves the nervous system It can cause numbness and tingling in the hands and feet Symptoms commonly improve when the drug is discontinued or the dose is lowered
Objectives
- To determine the safety and efficacy of Marqibo as a treatment for children who have been diagnosed with certain types of malignant cancer that has not responded to standard treatment
Eligibility
Children and adolescents between 2 and 21 years of age who have been diagnosed with certain types of malignant cancer that has not responded to standard treatment
These cancer types include solids tumors primary brain tumors leukemias and lymphomas
Detailed Description:
BACKGROUND
Vincristine sulfate is a widely used antineoplastic agent of the alkaloid class of drugs derived from the periwinkle plant Vinca rosea Linn It has activity against a wide number of malignancies It is a cell-cycle-specific agent that arrests cell growth in the M-phase metaphase by binding specifically with tubulin and disrupting cell division Its dose limiting toxicity DLT is virtually always neurological
Investigations over the past two decades have demonstrated that liposomal drug carriers are capable of increasing the therapeutic index of anticancer drugs by altering the drug s pharmacological behavior
MarqiboRegistered Trademark is vincristine encapsulated in sphingomyelincholesterol SMCHOL liposomes developed to increase the activity of vincristine It has been shown to have activity in Phase 2 studies in adults Previous investigation of MarqiboRegistered Trademark in children is limited A small phase 2 study was conducted with dosing of 20mgm2 every 14 days The agent appeared to be well tolerated and some activity was seen although data were quite limited
OBJECTIVES
To define the maximum tolerated dose MTD toxicity profile dose-limiting toxicities and pharmacokinetics in children and adolescents with solid tumors or hematologic malignancies receiving weekly intravenous doses of MarqiboRegistered Trademark
To define the tolerability and potential activity of MarqiboRegistered Trademark in children and adolescents with relapsed or refractory acute lymphoblastic leukemia ALL at the pediatric MTD
ELIGIBILITY
- Children and adolescents greater than or equal to 2 years and 21 years of age with histologically confirmed relapsed or refractory malignant disease that is measurable or evaluable
DESIGN
MarqiboRegistered Trademark will be administered intravenously over 60 minutes or -10 minutes every 7 days or - 3 days Days 1 8 15 22 for four doses 1 cycle Cycles may be repeated every 28 days for a maximum of 6 cycles additional cycles may be offered with evidence of acceptable toxicity and clinical benefit
The trial follows a standard phase I design with 3 to 6 subjects per dose level and standard definitions of MTD and DLT At the MTD a total of 6 additional subjects with relapsed or refractory ALL will be evaluated
Detailed pharmacokinetic studies will be performed during the first treatment cycle
Vincristine sulfate is a widely used antineoplastic agent of the alkaloid class of drugs derived from the periwinkle plant Vinca rosea Linn It has activity against a wide number of malignancies It is a cell-cycle-specific agent that arrests cell growth in the M-phase metaphase by binding specifically with tubulin and disrupting cell division Its dose limiting toxicity DLT is virtually always neurological
Investigations over the past two decades have demonstrated that liposomal drug carriers are capable of increasing the therapeutic index of anticancer drugs by altering the drug s pharmacological behavior
MarqiboRegistered Trademark is vincristine encapsulated in sphingomyelincholesterol SMCHOL liposomes developed to increase the activity of vincristine It has been shown to have activity in Phase 2 studies in adults Previous investigation of MarqiboRegistered Trademark in children is limited A small phase 2 study was conducted with dosing of 20mgm2 every 14 days The agent appeared to be well tolerated and some activity was seen although data were quite limited
OBJECTIVES
To define the maximum tolerated dose MTD toxicity profile dose-limiting toxicities and pharmacokinetics in children and adolescents with solid tumors or hematologic malignancies receiving weekly intravenous doses of MarqiboRegistered Trademark
To define the tolerability and potential activity of MarqiboRegistered Trademark in children and adolescents with relapsed or refractory acute lymphoblastic leukemia ALL at the pediatric MTD
ELIGIBILITY
- Children and adolescents greater than or equal to 2 years and 21 years of age with histologically confirmed relapsed or refractory malignant disease that is measurable or evaluable
DESIGN
MarqiboRegistered Trademark will be administered intravenously over 60 minutes or -10 minutes every 7 days or - 3 days Days 1 8 15 22 for four doses 1 cycle Cycles may be repeated every 28 days for a maximum of 6 cycles additional cycles may be offered with evidence of acceptable toxicity and clinical benefit
The trial follows a standard phase I design with 3 to 6 subjects per dose level and standard definitions of MTD and DLT At the MTD a total of 6 additional subjects with relapsed or refractory ALL will be evaluated
Detailed pharmacokinetic studies will be performed during the first treatment cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IND 59056 | REGISTRY | Talon Therapeutics | None |