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ARST0921 A Randomized Phase II Trial of Bevacizumab (Avastin) and Temsirolimus (Torisel) in Patients with Recurrent/Refractory Rhabdomyosarcoma

 

Purpose Of Study:

We are testing 2 experimental drug combinations in the hope of finding a new therapy for fighting the type of cancer that you have. The 2 drug combinations are:

vinorelbine and cyclophosphamide with bevacizumab
vinorelbine and cyclophosphamide with temsirolimus
Bevacizumab and temsirolimus are experimental anticancer drugs that have not yet been approved by the Food and Drug Administration for use in treating rhabdomyosarcoma that is not responding to treatment or has come back after treatment.

Bevacizumab and temsirolimus work differently than the drugs vinorelbine and cyclophosphamide. As tumors grow, they need new blood vessels to grow with them in order to receive nutrients and survive. Bevacizumab works by blocking the growth of blood vessels, including blood vessels in tumors. Temsirolimus blocks a protein called mTOR. mTOR is involved in tumor growth, including the growth of blood vessels.

In laboratory studies, both bevacizumab and temsirolimus have been shown to work against some types of childhood cancers, including rhabdomyosarcoma. Each of the 2 drugs has been given to children with cancer. But they have not been given along with vinorelbine and cyclophosphamide to people with recurrent or refractory rhabdomyosarcoma.

The goals of this study are:

To find out what effects (good and/or bad) bevacizumab, given with vinorelbine and cyclophosphamide, has on children and young adults with recurrent or refractory rhabdomyosarcoma

To find out what effects (good and/or bad) temsirolimus, given with vinorelbine and cyclophosphamide, has on children and young adults with recurrent or refractory rhabdomyosarcoma
To compare the effects of treatment with vinorelbine, cyclophosphamide and bevacizumab against the effects of treatment with vinorelbine, cyclophosphamide and temsirolimus

Who can participate:

Patients must have had a previous histological verification of rhabdomyosarcoma at original diagnosis
Patients with first relapse or progression of rhabdomyosarcoma are eligible
Patients with primary refractory disease are eligible
Primary refractory disease is defined as first progression after receiving at least one course of cyclophosphamide or ifosfamide containing chemotherapy without prior demonstration of a radiographic response to chemotherapy (progression on irinotecan-containing chemotherapy without cyclophosphamide or ifosfamide containing chemotherapy will not be considered a first (progression).
Patient must be < 30 years of age at the time of study enrollment.
Additional screening for eligibility will be required.

What will happen during the study:

Treatment
The treatment involves cancer fighting medicine called chemotherapy. Treatment will be given in cycles that last 3 weeks (21 days). You will get 2 cycles of treatment and then there will be an evaluation. An evaluation means that you will have tests and imaging studies (scans) done to see if the tumor has changed. If the tumor has not gotten larger and you do not have bad side effects, your doctor may suggest you continue with treatment. If this happens, up to 10 more cycles of treatment may be given, for a total of up to 12 cycles. You will stop getting treatment on this study if the tumor gets larger or comes back, or if side effects from the treatment are too severe. If that happens, your doctor will discuss other treatment options with you.

Random Assignment
You will receive 1 of 2 different treatment plans. The treatment plan that you receive is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer. You and your doctor will not pick which treatment you get. The randomization process is described in the COG Family Handbook for Children with Cancer.

Some subjects will be randomized to receive treatment on Arm A; others will be randomized to receive treatment on Arm B.

In this study you will get 1 of 2 treatment plans. The 2 treatment plans are the same except that some subjects will get the drug bevacizumab and some subjects will get the drug temsirolimus. The rest of the treatment with vinorelbine and cyclophosphamide will be the same.

The 2 treatment plans are called Arm A and Arm B as follows:
Arm A: vinorelbine and cyclophosphamide and bevacizumab (VC + B)
Arm B: vinorelbine and cyclophosphamide and temsirolimus (VC + T)

Timing
People in this clinical trial may get treatment on this study for up to 36 weeks. After treatment, you will have follow-up examinations and medical tests.

Who to contact:

Mark Ranalli, MD, Principal Investigator
(614) 722-3563
Mark.Ranalli@NationwideChildrens.org

Nationwide Children's Hospital
700 Children's Drive Columbus, Ohio 43205 614.722.2000