Lymphoma Clinical Trial
Official title:
Phase I Trial to Evaluate the Safety, Activity and Pharmacokinetics of Marqibo(Registered Trademark) (Vincristine Sulfate Liposomes Injection) in Children and Adolescents With Refractory Cancer
Background:
- Marqibo(Registered 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 drug's 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 Marqibo(Registered 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 Marqibo(Registered 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
Marqibo(Registered 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.
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.
- Marqibo(Registered Trademark) is vincristine encapsulated in sphingomyelin/cholesterol
(SM/CHOL) liposomes, developed to increase the activity of vincristine. It has been
shown to have activity in Phase 2 studies in adults. Previous investigation of
Marqibo(Registered Trademark) in children is limited. A small phase 2 study was
conducted with dosing of 2.0mg/m2 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 Marqibo(Registered Trademark).
- To define the tolerability and potential activity of Marqibo(Registered 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
- Marqibo(Registered 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.
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