Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma
Official Title
A Phase I Study Of Medi 522 In Patients With Advanced Tumors
Acronym
Not provided
Organization
University of Wisconsin, MadisonOTHER
Status Module
Record Verification Date
Jul 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
Not provided
Start Date
Oct 2002
Primary Completion Date
Feb 2006Actual
Completion Date
Feb 2006Actual
First Submitted Date
Nov 12, 2002
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 12, 2019
Last Update Posted Date
Dec 13, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University of Wisconsin, MadisonOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have refractory advanced solid tumors or lymphoma.
Detailed Description
OBJECTIVES:
Determine the maximum tolerated dose (MTD) of monoclonal antibody anti-alpha V beta 3 integrin (MEDI 522) in patients with refractory advanced solid tumors or lymphoma.
Determine the safety and tolerability of this drug in these patients.
Demonstrate significant binding of this drug to its molecular target in vivo in these patients.
Determine the effects of this drug on angiogenesis in these patients.
Determine antitumor activity of this drug by measuring tumor size and glucose uptake in these patients.
Determine the pharmacokinetics of this drug in these patients.
Determine a recommended phase II dose of this drug based on either the MTD or the optimal biologic response in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive monoclonal antibody anti-alpha V beta 3 integrin (Medi 522) IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 6 patients receive escalating doses of Medi 522 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: Approximately 6-30 patients will be accrued for this study.
Conditions Module
Conditions
Lymphoma
Small Intestine Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
intraocular lymphoma
primary central nervous system lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
etaracizumab
Biological
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed solid tumor or lymphoma that is refractory to currently available standard therapies or for which there are no curative therapies
No known brain metastases
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
ECOG 0-2
Life expectancy
More than 12 weeks
Hematopoietic
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No prior bleeding disorder
Hepatic
Bilirubin normal
AST/ALT no greater than 2.5 times upper limit of normal
INR/PTT normal
Renal
Creatinine normal OR
Creatinine clearance at least 60 mL/min
Cardiovascular
No symptomatic congestive heart failure
No unstable angina pectoris
No cardiac arrhythmia
Other
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study participation
HIV negative
T4 or thyroid stimulating hormone normal
No thyroid disease
No prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (e.g., rituximab or immunoglobulin G)
No ongoing or active infection
No other uncontrolled concurrent illness that would preclude study participation
No psychiatric illness or social situation that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
Endocrine therapy
Not specified
Radiotherapy
More than 4 weeks since prior radiotherapy and recovered
Surgery
More than 4 weeks since prior surgery
Other
No other concurrent investigational agents
No other concurrent anticancer agents or therapies (commercial or investigational)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Douglas McNeel, MD, PhD
University of Wisconsin, Madison
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Wisconsin Comprehensive Cancer Center
Madison
Wisconsin
53792
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D008223
Lymphoma
D017728
Lymphoma, Large-Cell, Anaplastic
D007119
Immunoblastic Lymphadenopathy
D064090
Intraocular Lymphoma
D016403
Lymphoma, Large B-Cell, Diffuse
D008228
Lymphoma, Non-Hodgkin
D002051
Burkitt Lymphoma
D006689
Hodgkin Disease
D016400
Lymphoma, Large-Cell, Immunoblastic
D054198
Precursor Cell Lymphoblastic Leukemia-Lymphoma
D054218
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
D016410
Lymphoma, T-Cell, Cutaneous
D008224
Lymphoma, Follicular
D020522
Lymphoma, Mantle-Cell
D009182
Mycosis Fungoides
D012751
Sezary Syndrome
D018442
Lymphoma, B-Cell, Marginal Zone
Ancestor Terms
ID
Term
D009370
Neoplasms by Histologic Type
D009369
Neoplasms
D008232
Lymphoproliferative Disorders
D008206
Lymphatic Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
C112567
etaracizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
recurrent mantle cell lymphoma
recurrent mycosis fungoides/Sezary syndrome
small intestine lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Burkitt lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult T-cell leukemia/lymphoma
stage IV cutaneous T-cell non-Hodgkin lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV mycosis fungoides/Sezary syndrome
unspecified adult solid tumor, protocol specific
stage IV adult lymphoblastic lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Burkitt lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III cutaneous T-cell non-Hodgkin lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III mycosis fungoides/Sezary syndrome
stage III adult T-cell leukemia/lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
stage III small lymphocytic lymphoma
stage III marginal zone lymphoma
stage IV small lymphocytic lymphoma
stage IV marginal zone lymphoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue