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Monoclonal Antibody Therapy in Treating Patients With Refractory Advanced Solid Tumors or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00049712
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific Biological: etaracizumab Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase I Study Of Medi 522 In Patients With Advanced Tumors
Study Start Date : October 2002
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049712


Locations
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United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
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Study Chair: Douglas McNeel, MD, PhD University of Wisconsin, Madison
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00049712    
Other Study ID Numbers: CDR0000257810
P30CA014520 ( U.S. NIH Grant/Contract )
WCCC-CO-01905
NCI-5497
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: July 2015
Keywords provided by University of Wisconsin, Madison:
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
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
Additional relevant MeSH terms:
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Lymphoma
Intestinal Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases