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Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
This study has been withdrawn prior to recruitment.
Study NCT00052403   Information provided by National Cancer Institute (NCI)
First Received: January 24, 2003   Last Updated: January 11, 2007   History of Changes

January 24, 2003
January 11, 2007
 
 
 
 
Complete list of historical versions of study NCT00052403 on ClinicalTrials.gov Archive Site
 
 
 
Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors

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.

OBJECTIVES:

  • 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.

Phase I
Interventional
Treatment
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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Withdrawn
 
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

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

Hepatic

  • Bilirubin no greater than 1.2 mg/dL
  • ALT and AST no greater than 2.5 times upper limit of normal (ULN)
  • PT/PTT no greater than ULN

Renal

  • Creatinine less than 1.5 mg/dL 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
  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior immunotherapy

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

Radiotherapy

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

Surgery

  • More than 4 weeks since prior surgery

Other

  • No other concurrent investigational or commercial agents or therapies for the malignancy
  • No other concurrent antitumor therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00052403
 
CDR0000258300, WSU-C-2453, NCI-5496
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Study Chair: Patricia LoRusso, DO Harper Hospital
National Cancer Institute (NCI)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP