Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors

This study has been withdrawn prior to enrollment.
(Study was not successful at recruiting particpants)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Patricia LoRusso, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00052403
First received: January 24, 2003
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Enrollment: 0
Study Start Date: February 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

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

  • Eastern Cooperative Oncology Group (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
  • 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

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

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052403

Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Patricia LoRusso, DO Harper Hospital
  More Information

No publications provided

Responsible Party: Patricia LoRusso, Principal Investigator, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00052403     History of Changes
Other Study ID Numbers: CDR0000258300, WSU-C-2453, NCI-5496
Study First Received: January 24, 2003
Last Updated: January 15, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on April 17, 2014