Lorvotuzumab Mertansine in Treating Younger Patients With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor, or Synovial Sarcoma



Status:Active, not recruiting
Conditions:Lung Cancer, Cancer, Brain Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:Any - 30
Updated:8/9/2018
Start Date:October 12, 2015

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A Phase 2 Study of IMGN901 (Lorvotuzumab Mertansine; NSC#: 783609) in Children With Relapsed or Refractory Wilms Tumor, Rhabdomyosarcoma, Neuroblastoma, Pleuropulmonary Blastoma, Malignant Peripheral Nerve Sheath Tumor (MPNST) and Synovial Sarcoma

This phase II trial studies how well lorvotuzumab mertansine works in treating younger
patients with Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary blastoma,
malignant peripheral nerve sheath tumor (MPNST), or synovial sarcoma that has returned or
that does not respond to treatment. Antibody-drug conjugates, such as lorvotuzumab
mertansine, are created by attaching an antibody (protein used by the body?s immune system to
fight foreign or diseased cells) to an anti-cancer drug. The antibody is used to recognize
tumor cells so the anti-cancer drug can kill them.

PRIMARY OBJECTIVES:

I. To assess the efficacy of IMGN901 (lorvotuzumab mertansine) in Wilms tumor,
rhabdomyosarcoma, neuroblastoma and other cluster of differentiation (CD)56-expressing tumors
such as pleuropulmonary blastoma, malignant peripheral nerve sheath tumor (MPNST) and
synovial sarcoma.

II. To determine the tolerability of the adult recommended phase 2 dose (RP2D) of IMGN901
administered as an intravenous infusion, administered on days 1 and 8 of a 21-day cycle, to
children with refractory Wilms tumor, rhabdomyosarcoma, neuroblastoma, pleuropulmonary
blastoma, MPNST, or synovial sarcoma.

III. To define and describe the toxicities of IMGN901 administered on this schedule.

SECONDARY OBJECTIVES:

I. To correlate tumor response with tumor CD56+ expression. II. To characterize the
pharmacokinetics of IMGN901 in children with refractory cancer, including an assessment of
impact on circulating CD56+ peripheral blood cells.

OUTLINE:

Patients receive lorvotuzumab mertansine intravenously (IV) over 1-1.5 hours on days 1 and 8.
Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up for 5 years.

Inclusion Criteria:

- Patients must have had histologic verification of one of the malignancies listed below
at original diagnosis or at relapse

- Primary strata

- Wilms tumor

- Rhabdomyosarcoma

- Neuroblastoma

- Secondary strata: miscellaneous CD56-expressing tumors:

- Pleuropulmonary blastoma

- Malignant peripheral nerve sheath tumor (MPNST)

- Synovial sarcoma

- Patients must have radiographically measurable disease (with the exception of those
with neuroblastoma)

- Measurable disease is defined as the presence of at least one lesion on magnetic
resonance imaging (MRI) or computed tomography (CT) scan that can be accurately
measured with the longest diameter a minimum of 10 mm in at least one dimension
(CT scan slice thickness no greater than 5 mm)

- Note: the following do not qualify as measurable disease:

- Malignant fluid collections (e.g., ascites, pleural effusions)

- Bone marrow infiltration except that detected by metaiodobenzylguanidine
(MIBG) scan for neuroblastoma

- Lesions only detected by nuclear medicine studies (e.g., bone, gallium or
positron emission tomography [PET] scans) except as noted in patients with
neuroblastoma who do not have measurable disease but have MIBG-avid
evaluable disease

- Elevated tumor markers in plasma or cerebrospinal fluid (CSF)

- Previously radiated lesions that have not demonstrated clear progression
post radiation

- Leptomeningeal lesions that do not meet the measurements noted above

- Patients with neuroblastoma who do not have measurable disease but have MIBG-avid
evaluable disease are eligible

- Patients must have a Lansky or Karnofsky performance status score of >= 50,
corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2; use
Karnofsky for patients > 16 years of age and Lansky for patients =< 16 years of age;
patients who are unable to walk because of paralysis, but who are up in a wheelchair,
will be considered ambulatory for the purpose of assessing the performance score

- Patients must have fully recovered from the acute toxic effects of all prior
chemotherapy, immunotherapy, or radiotherapy prior to entering this study

- Patients must have received standard treatment appropriate for their tumor type

- Myelosuppressive chemotherapy: patients with solid tumors must not have received
myelosuppressive chemotherapy within 3 weeks of enrollment onto this study (6
weeks if prior nitrosourea)

- Hematopoietic growth factors: at least 14 days must have elapsed after receiving
pegfilgrastim and least 7 days must have elapsed since the completion of therapy
with a non-pegylated growth factor

- Biologic (anti-neoplastic agent): at least 7 days must have elapsed since
completion of therapy with a biologic agent; for agents that have known adverse
events occurring beyond 7 days after administration, this period prior to
enrollment must be extended beyond the time during which adverse events are known
to occur

- Monoclonal antibodies: at least 3 half-lives must have elapsed since prior
therapy that included a monoclonal antibody

- Radiotherapy: >= 2 weeks must have elapsed since local palliative external beam
radiation therapy (XRT) (small port); >= 6 weeks must have elapsed since
treatment with therapeutic doses of MIBG; >= 3 months must have elapsed if prior
craniospinal XRT was received, if >= 50% of the pelvis was irradiated, or if
total body irradiation (TBI) was received; >= 6 weeks must have elapsed if other
substantial bone marrow irradiation was given

- Stem cell transplant or rescue without TBI: no evidence of active graft vs. host
disease and >= 2 months must have elapsed since transplant

- For patients with solid tumors without bone marrow involvement: peripheral absolute
neutrophil count (ANC) >= 1000/uL

- For patients with solid tumors without bone marrow involvement: platelet count >=
100,000/uL (transfusion independent, defined as not receiving platelet transfusions
within a 7 day period prior to enrollment)

- For patients with solid tumors and known bone marrow metastatic disease: peripheral
absolute neutrophil count (ANC) >= 750/uL

- For patients with solid tumors and known bone marrow metastatic disease: platelet
count >= 75,000/uL (transfusion independent, defined as not receiving platelet
transfusions for at least 7 days prior to enrollment)

- 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:

- Age 1 to < 2 years: maximum serum creatinine: 0.6 mg/dL in males and females

- Age 2 to < 6 years: maximum serum creatinine: 0.8 mg/dL in males and females

- Age 6 to < 10 years: maximum serum creatinine: 1 mg/dL in males and females

- Age 10 to < 13 years: maximum serum creatinine: 1.2 mg/dL in males and females

- Age 13 to < 16 years: maximum serum creatinine: 1.5 mg/dL in males and 1.4 mg/dL
in females

- Age >= 16 years: maximum serum creatinine: 1.7 mg/dL in males and 1.4 mg/dL in
females

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

- Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110
U/L (for the purpose of this study, the ULN for SGPT is 45 U/L)

- Serum albumin >= 2 g/dL

- Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by
gated radionuclide study

- Patients with seizure disorder may be enrolled if on anticonvulsants and well
controlled

- 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 are pregnant or breast-feeding are not eligible for this study; negative
pregnancy tests must be obtained in girls who are post-menarchal; males or females of
reproductive potential may not participate unless they have agreed to use an effective
contraceptive method for the duration of study therapy and for 4 weeks after the last
dose of study therapy; breastfeeding women are excluded

- Concomitant medications

- Corticosteroids: patients requiring corticosteroids who have not been on a stable
or decreasing dose of corticosteroid for the 7 days prior to enrollment are not
eligible

- Patients who have received previous treatment with IMGN901 are not eligible

- Investigational drugs: patients who are currently receiving another
investigational drug are not eligible

- Anti-cancer agents: patients who are currently receiving other anti-cancer agents
are not eligible

- Anti-graft-versus-host disease (GVHD) or agents to prevent organ rejection
post-transplant: patients who are receiving cyclosporine, tacrolimus or other
agents to prevent either graft-versus-host disease post bone marrow transplant or
organ rejection post-transplant are not eligible for this trial

- Patients who have a CNS toxicity > grade 2 are not eligible

- Patients must not have known active central nervous system (CNS) metastases; patients
with known central nervous system metastases are excluded unless treated surgically or
with radiotherapy, and stable with no recurrent lesions for at least 6 months

- Patients who have baseline peripheral neuropathy >= grade 2 are not eligible

- Patients who have an uncontrolled infection are not eligible

- Patients who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study are not eligible
We found this trial at
69
sites
111 Michigan Ave NW
Washington, District of Columbia
(202) 476-5000
Principal Investigator: Jeffrey S. Dome
Phone: 202-476-5685
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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Austin, TX
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1600 7th Avenue
Birmingham, Alabama 35233
(205) 638-9100
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
802-656-8990
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: James I. Geller
Phone: 513-636-3549
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
(216) 844-1000
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Rachel C. Brennan
Phone: 901-521-9005
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Principal Investigator: Ivan I. Kirov
Phone: 714-509-8699
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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530 Northeast Glen Oak Avenue
Peoria, Illinois 61603
(309) 624-4945
Saint Jude Midwest Affiliate The Jim and Trudy Maloof St. Jude Midwest Affiliate Clinic was...
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Principal Investigator: Elizabeth Fox
Phone: 267-425-0113
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Jean M. Tersak
Phone: 412-692-7693
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
(877) 475-6688
C S Mott Children's Hospital Behind the doors of C.S. Mott Children's Hospital there exist...
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Atlanta, Georgia 30322
Principal Investigator: William T. Cash
Phone: 404-727-4455
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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489 State St
Bangor, Maine 04401
(207) 973-7000
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Chicago, Illinois 60614
Principal Investigator: Stewart Goldman
Phone: 312-227-9756
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
(803) 434-7000
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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9333 Imperial Highway
Downey, California 90242
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801 Broadway North
Fargo, North Dakota 58122
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, Indiana 46260
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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1 Children's Way
Little Rock, Arkansas 72202
(501) 364-1100
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Miami, Florida 33155
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
(414) 266-2000
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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Minneapolis, Minnesota 55455
Principal Investigator: Emily G. Greengard
Phone: 612-626-2815
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2525 Chicago Ave
Minneapolis, Minnesota 55404
(612) 813-6000
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Morgantown, West Virginia 26505
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Nashville, Tennessee 37232
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New Orleans, Louisiana 70121
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New York, New York 10032
Principal Investigator: Alice Lee
Phone: 212-305-5848
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New York, New York 10029
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Orlando, Florida 32803
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Rochester, Minnesota 55905
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Robert J. Hayashi
Phone: 314-454-2780
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, Missouri 63141
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Saint Petersburg, Florida 33701
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Salt Lake City, Utah 84143
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San Francisco, California 94158
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Scarborough, Maine 04074
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
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