Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors

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. Identifier: NCT00052403
Recruitment Status : Withdrawn (Study was not successful at recruiting particpants)
First Posted : January 27, 2003
Last Update Posted : January 16, 2014
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute

Brief Summary:

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-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 advanced solid tumors.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: monoclonal antibody anti-anb3 integrin Procedure: anti-cytokine therapy Procedure: antiangiogenesis therapy Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: growth factor antagonist therapy Procedure: monoclonal antibody therapy Phase 1

Detailed Description:


  • Determine the maximum tolerated dose and recommended phase II dose of monoclonal antibody anti-anb3 integrin in patients with advanced solid tumors.
  • Determine the toxic effects of this drug in these patients.
  • Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
  • Determine the potential anti-tumor activity of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive monoclonal antibody anti-anb3 integrin IV over 30 minutes weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of monoclonal antibody anti-anb3 integrin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated as above at that dose level.

PROJECTED ACCRUAL: A total of 27-33 patients will be accrued for this study within 9-11 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors
Study Start Date : February 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria


  • Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective treatment exists
  • Measurable or evaluable disease
  • Must have clinical or radiological evidence of disease
  • Disease must be accessible to biopsy and imaging studies
  • No known brain metastases



  • 18 and over

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-2

Life expectancy

  • At least 3 months


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3
  • No prior bleeding disorder


  • Bilirubin no greater than 1.2 mg/dL
  • alanine aminotransferase test (ALT) and Aspartate Aminotransferase (AST) no greater than 2.5 times upper limit of normal (ULN)
  • Prothrombin time (PT)/ partial thromboplastin time (PTT) no greater than ULN


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min


  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study
  • Willing to be premedicated for delayed contrast-enhanced MRI
  • No prior claustrophobia
  • No dementia or altered mental status that would preclude informed consent
  • No other uncontrolled concurrent illness
  • No ongoing or active infection
  • No psychiatric illness or social situations that would preclude study compliance
  • No immunodeficiency
  • HIV negative
  • Must be willing to receive blood products
  • No thyroid disease
  • Thyroxine and thyroid-stimulating hormone no greater than ULN


Biologic therapy

  • At least 4 weeks since prior immunotherapy

Exclusion Criteria Chemotherapy

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • Prior taxanes allowed
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy except:
  • Concurrent hormonal replacement therapy
  • Concurrent medication for maintaining castrate status in patients with progressive hormone refractory prostate cancer


  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 25% of the bone marrow
  • No concurrent radiotherapy


  • More than 4 weeks since prior surgery


  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No other concurrent antitumor therapy

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 identifier (NCT number): NCT00052403

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Patricia LoRusso, DO Harper Hospital

Responsible Party: Patricia LoRusso, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT00052403     History of Changes
Other Study ID Numbers: CDR0000258300
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Antibodies, Monoclonal
Antibodies, Anti-Idiotypic
Immunologic Factors
Physiological Effects of Drugs
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action