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Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With 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.

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

- 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Patricia LoRusso, DO

Investigator Role:

Study Chair

Investigator Affiliation:

Harper Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000258300

NCT ID:

NCT00052403

Start Date:

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • Neoplasms

Name

Location

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201