Clinical trial NCT01461538: Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Official title: A Phase 2, Open-label Study of Brentuximab Vedotin in Patients With CD30-positive Nonlymphomatous Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoid Leukemia
Acute Myeloid Leukemia
Anemia, Refractory, With Excess of Blasts
Solid Tumors
Keywords: Acute Lymphoid Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Solid Tumors
Anemia, Refractory, with Excess of Blasts
Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Drug Therapy
Hematologic Diseases
Immunotherapy
Monomethyl Auristatin E
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open-label, multicenter, phase 2 clinical trial to evaluate the antitumor activity of brentuximab vedotin as a single agent in patients with CD30-positive nonlymphomatous malignancies.


Eligibility criteria: Inclusion Criteria:

* Histologically-confirmed by central review CD30-positive nonlymphomatous malignancy
* Have failed, refused, or have been deemed ineligible for standard therapy
* Measurable disease
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 or a Karnofsky or Lansky Performance Status score greater than or equal to 70

Exclusion Criteria:

* Primary diagnosis of lymphoma or central nervous system (CNS) malignancy
* History of another primary invasive malignancy that has not been definitively treated or in remission for at least 3 years
* Evidence of active cerebral/meningeal disease

Primary outcomes:
measure: Objective Response Rate (ORR) by Investigator
timeFrame: Up to approximately 3 years
Secondary outcomes:
measure: Complete Remission (CR) Rate by Investigator
timeFrame: Up to approximately 3 years
measure: Duration of Objective Response by Kaplan-Meier Analysis
timeFrame: Up to approximately 2 years
measure: Duration of Complete Response by Kaplan-Meier Analysis
timeFrame: Up to approximately 2 years
measure: Progression-Free Survival by Kaplan-Meier Analysis
timeFrame: Up to approximately 2 years
measure: Adverse Events by Severity, Seriousness, and Relationship to Treatment
timeFrame: Up to approximately 3 years
measure: Laboratory Abnormalities >/= Grade 3
timeFrame: Up to approximately 3 years
measure: Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi)
timeFrame: Up to approximately 3 years
measure: Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough)
timeFrame: Up to approximately 3 years
measure: Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)
timeFrame: Up to approximately 3 years
measure: Brentuximab Vedotin Monomethyl Auristatin E (MMAE) Trough Concentration (Ctrough)
timeFrame: Up to approximately 3 years
measure: Incidence of Anti-therapeutic Antibodies (ATA)
timeFrame: Up to approximately 3 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope
state: California
city: Oxnard
country: United States
facility: PMK Medical Group Inc., DBA Ventura County Hematology Oncology Specialists
state: California
city: Aurora
country: United States
facility: Rocky Mountain Cancer Centers - Aurora
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic Cancer Center
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Indianapolis
country: United States
facility: Indiana University Simon Cancer Center
state: Indiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology P.A.
state: Minnesota
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Valley Cancer and Research / USOR
state: Oregon
city: Tulatin
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Oregon
city: Greenville
country: United States
facility: St. Francis Hospital
state: South Carolina
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian
state: Texas
city: Denton
country: United States
facility: Texas Oncology Denton South
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Fort Worth 12th Avenue
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center / University of Texas
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center Leukemia Group
state: Texas
city: Round Rock
country: United States
facility: Texas Oncology - Central Austin Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Centers of South Texas - HOAST
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Blacksburg
country: United States
facility: Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
state: Virginia
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Memorial Hospital / North Star Lodge
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Neil Josephson, MD
role: STUDY_DIRECTOR
References:
citation: Albany C, Einhorn L, Garbo L, Boyd T, Josephson N, Feldman DR. Treatment of CD30-Expressing Germ Cell Tumors and Sex Cord Stromal Tumors with Brentuximab Vedotin: Identification and Report of Seven Cases. Oncologist. 2018 Mar;23(3):316-323. doi: 10.1634/theoncologist.2017-0544. Epub 2017 Dec 8.
citation: Borate U, Mehta A, Reddy V, Tsai M, Josephson N, Schnadig I. Treatment of CD30-positive systemic mastocytosis with brentuximab vedotin. Leuk Res. 2016 May;44:25-31. doi: 10.1016/j.leukres.2016.02.010. Epub 2016 Feb 27.
citation: Giannatempo P, Paolini B, Miceli R, Raggi D, Nicolai N, Fare E, Catanzaro M, Biasoni D, Torelli T, Stagni S, Piva L, Mariani L, Salvioni R, Colecchia M, Gianni AM, Necchi A. Persistent CD30 expression by embryonal carcinoma in the treatment time course: prognostic significance of a worthwhile target for personalized treatment. J Urol. 2013 Nov;190(5):1919-24. doi: 10.1016/j.juro.2013.04.057. Epub 2013 Apr 25.