Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 40
Updated:4/6/2019
Start Date:May 23, 2016

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A Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating With Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients With Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

This randomized phase III trial studies how well combination chemotherapy (vincristine
sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan
hydrochloride or vinorelbine) works compared to combination chemotherapy plus temsirolimus in
treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as
muscle), and has an intermediate chance of coming back after treatment (intermediate risk).
Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either
by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some
of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy
or combination chemotherapy plus temsirolimus is more effective in treating patients with
intermediate-risk rhabdomyosarcoma.

PRIMARY OBJECTIVES:

I. To compare the event-free survival (EFS) of patients with intermediate-risk (IR)
rhabdomyosarcoma (RMS) treated with surgery, radiotherapy, and vincristine (vincristine
sulfate), dactinomycin, and cyclophosphamide (VAC) alternating with vincristine and
irinotecan (irinotecan hydrochloride) (VI) (VAC/VI) with maintenance to that of patients
treated with surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.

SECONDARY OBJECTIVES:

I. To compare the overall survival (OS) of patients with IR RMS treated with surgery,
radiotherapy, and VAC alternating with VI with maintenance to that of patients treated with
surgery, radiotherapy and VAC/VI plus temsirolimus with maintenance.

EXPLORATORY OBJECTIVES:

I. To compare the outcome of patients based on their forkhead box O1 protein (FOXO1) fusion
gene partner, by evaluating paired box (PAX) 3 versus (vs) PAX7 in all patients found to be
FOXO1 fusion positive.

II. To compare the outcome of patients based on their [F18]-fluorodeoxy-D-glucose-positron
emission tomography (FDG-PET) response at week 9 (positive or negative), as assessed by
Deauville criteria (5-point).

III. To estimate the frequency of patients with circulating tumor deoxyribonucleic acid (DNA)
(ctDNA) at diagnosis and subsequent time-points.

IV. To compare the outcome of patients (VAC/VI with or without temsirolimus) who have
received maintenance therapy on ARST1431 to those who received VAC/VI on ARST0531.

OUTLINE:

FEASIBILITY PHASE (THE FEASIBILITY PHASE IS COMPLETE, EFFECTIVE WITH AMENDMENT #1A): (< 21
years old): This is a dose-escalation study of temsirolimus.

Patients receive vincristine sulfate intravenously (IV) over 1 minute on day 1 of weeks 1-13,
16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 minutes on day 1
of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of weeks
1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5 of
weeks 4, 10, 16, 19, 25, 31, and 37, and temsirolimus IV over 30-60 minutes on days 1, 8, and
15. Patients also undergo radiation therapy (RT) beginning week 13 for up to 6.5 weeks.
Courses with temsirolimus repeat every 21 days for 12 weeks in the absence of disease
progression or unacceptable toxicity.

EFFICACY PHASE: Patients are randomized to Regimen A or B. Patients with disease that is ARMS
FOXO1 fusion negative (stage I, group I/II, stage 1, group III [orbit] or stage II, group
I/II) are assigned to Regimen C.

REGIMEN A (VAC/VI): Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks
1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5 minutes on
day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes on day 1 of
weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes on days 1-5
of weeks 4, 10, 16, 19, 25, 31, and 37. Patients also undergo primary site RT beginning at
week 13 or metastatic site RT beginning at week 43 for up to 6.5 weeks. Treatment continues
in the absence of disease progression or unacceptable toxicity. Patients then receive
vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once
daily (QD) on days 1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease
progression or unacceptable toxicity.

REGIMEN B (VAC/VI TEMSIROLIMUS): Patients receive vincristine sulfate IV over 1 minute on day
1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40, dactinomycin IV over 1-5
minutes on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, cyclophosphamide IV over 60 minutes
on day 1 of weeks 1, 7, 13, 22, 28, 34, and 40, irinotecan hydrochloride IV over 90 minutes
on days 1-5 of weeks 4, 10, 16, 19, 25, 31, and 37 and temsirolimus IV over 30-60 minutes on
day 1 of weeks 1-12 and 21-42. Patients also undergo RT as in Regimen A. Treatment continues
in the absence of disease progression or unacceptable toxicity. Patients then receive
vinorelbine IV over 6-10 minutes on days 1, 8, and 15 and cyclophosphamide PO QD on days
1-28. Cycles repeats every 28 days for 24 weeks in the absence of disease progression or
unacceptable toxicity.

MAINTENANCE PHASE (Patients in Regimen A or Regimen B): Patients receive vinorelbine IV over
6-10 minutes on days 1, 8, and 15 and cyclophosphamide orally (PO) once daily (QD) on days
1-28. Treatment repeats every 28 days for up to 6 cycles.

REGIMEN C (FOXO1 FUSION NEGATIVE): Patients receive vincristine sulfate IV over 1 minute on
day 1 of weeks 1-10 and 13-22, dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 7,
10, 13, 16, 19, and 22, cyclophosphamide IV over 60 minutes on day 1 of weeks 1, 4, 7, and
10. Patients undergo RT beginning at week 13 for up to 6.5 weeks. Treatment continues in the
absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year,
every 4 months for 2 years, every 6 months for 1 year, and then annually for up to 10 years.

Inclusion Criteria:

- Feasibility Phase: Patients must be < 21 years of age at the time of enrollment;
please note: the feasibility phase is complete, effective with amendment #1

- Efficacy Phase: Patients must be =< 40 years of age at the time of enrollment

- Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based
upon institutional histopathologic classification, are eligible to enroll on the study
based upon stage, group, and age, as below

- RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in
the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic,
spindle cell, and botryoid variants), which are reclassified in the 2013 World Health
Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and
spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and
the newly recognized sclerosing RMS variant); classification of alveolar
rhabdomyosarcoma (ARMS) in the 2013 WHO classification is the same as in the ICR and
includes classic and solid variants

- ERMS

- Stage 1, group III (non-orbit)

- Stage 3, group I/II

- Stage 2/3, group III

- Stage 4, group IV, < 10 years old

- ARMS:

- Stages 1-3, groups I-III

- Specimen Submission: Patients must have sufficient tissue available for the required
biology study

- Lansky performance status score >= 50 for patients =< 16 years of age; Karnofsky
performance status score >= 50 for patients > 16 years of age

- Peripheral absolute neutrophil count (ANC) >= 750/uL

- Platelet count >= 75,000/uL

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- 1 month to < 6 months old: 0.4 mg/dl (male), 0.4 mg/dl (female)

- 6 months to < 1 year old: 0.5 mg/dl (male), 0.5 mg/dl (female)

- 1 to < 2 years old: 0.6 mg/dl (male), 0.6 mg/dl (female)

- 2 to < 6 years old: 0.8 mg/dl (male), 0.8 mg/dl (female)

- 6 to < 10 years old: 1 mg/dl (male), 1 mg/dl (female)

- 10 to < 13 years old: 1.2 mg/dl (male), 1.2 mg/dl (female)

- 13 to < 16 years old: 1.5 mg/dl (male), 1.4 mg/dl (female)

- >= 16 years old: 1.7 mg/dl (male), 1.4 mg/dl (female)

- Patients with an elevated serum creatinine due to obstructive hydronephrosis
secondary to tumor are still eligible; however, patients with urinary tract
obstruction by tumor must have unimpeded urinary flow established via diversion
(i.e. percutaneous nephrostomies or ureteric stents) of the urinary tract

- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age

- All patients and/or their parents or legal guardians must sign a written informed
consent.

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.

Exclusion Criteria:

- Patients who have previously received temsirolimus, another mTOR inhibitor, or any
other investigational agent

- Patients who have received any chemotherapy (excluding steroids) and/or RT prior to
this enrollment

- Patients with uncontrolled hyperglycemia

- Patients with uncontrolled hyperlipidemia

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation and for
at least 3 months after treatment is completed

- Female patients who are pregnant are not eligible; Note: a pregnancy test is required
for female patients of childbearing potential prior to study entry

- Lactating females who plan to breastfeed their infants are not eligible
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Nadine P. SantaCruz
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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Bellflower, California 90706
Principal Investigator: Robert M. Cooper
Phone: 800-398-3996
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Bellingham, Washington 98225
Principal Investigator: Dan S. Zuckerman
Phone: 360-715-4133
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Bend, Oregon 97701
Principal Investigator: Dan S. Zuckerman
Phone: 541-706-2909
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Berlin, Vermont 05602
Principal Investigator: Jessica L. Heath
Phone: 802-225-5400
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Berlin, VT
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Eugenia Chang
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, ID
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55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Katherine A. Janeway
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Katherine A. Janeway
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, Massachusetts 02111
Principal Investigator: Michael J. Kelly
Phone: 617-636-5535
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Bridgeport, West Virginia 26330
Principal Investigator: Stephan R. Paul
Phone: 304-293-7374
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Bridgeport, WV
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Bronx, New York 10461
Principal Investigator: Lisa Gennarini
Phone: 718-379-6866
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Bronx, NY
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Bronx, New York 10461
Principal Investigator: Lisa Gennarini
Phone: 718-379-6866
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Bronx, New York 10467
Principal Investigator: Lisa Gennarini
Phone: 718-379-6866
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Burbank, California
Principal Investigator: Dan S. Zuckerman
Phone: 818-847-4793
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Burlington, Vermont 05405
Principal Investigator: Jessica L. Heath
Phone: 802-656-4101
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Carson City, Nevada 89703
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Centralia, Washington 98531
Principal Investigator: Dan S. Zuckerman
Phone: 360-412-8958
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Centralia, WA
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Chapel Hill, North Carolina 27599
Principal Investigator: Stuart H. Gold
Phone: 877-668-0683
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Jacqueline M. Kraveka
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28204
Principal Investigator: Joel A. Kaplan
Phone: 800-804-9376
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Charlotte, North Carolina 28204
Principal Investigator: Jessica A. Bell
Phone: 704-384-5369
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Charlotte, North Carolina 28207
Principal Investigator: Jessica A. Bell
Phone: 704-384-8920
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Charlotte, North Carolina 28207
Principal Investigator: Jessica A. Bell
Phone: 704-384-8920
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Charlotte, North Carolina 28262
Principal Investigator: Jessica A. Bell
Phone: 704-384-8920
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Chattanooga, Tennessee 37403
Principal Investigator: Manoo G. Bhakta
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Susan L. Cohn
Phone: 773-702-8222
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, Illinois 60614
Principal Investigator: David O. Walterhouse
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1969 W Ogden Ave
Chicago, Illinois 60612
(312) 864-6000
Principal Investigator: Mary L. Schmidt
Phone: 312-864-5204
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Mary L. Schmidt
Phone: 312-942-5498
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Mary L. Schmidt
Phone: 312-355-3046
Univ of Illinois A major research university in the heart of one of the world's...
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Clackamas, Oregon 97015
Principal Investigator: Dan S. Zuckerman
Phone: 503-215-2614
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Dan S. Zuckerman
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Rabi Hanna
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbia, Missouri 65201
Principal Investigator: Barbara A. Gruner
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Principal Investigator: Stuart L. Cramer
Phone: 803-434-3680
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Coos Bay, Oregon 97420
Principal Investigator: Dan S. Zuckerman
Phone: 541-269-8392
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