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

Lymphoma Clinical Trial

Official title:

A Phase I Study Of Medi 522 In Patients With Advanced Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049712
• Other study ID #: CDR0000257810
• Secondary ID: P30CA014520WCCC-
• Status: Completed
• Phase: Phase 1
• Start date: October 2002
• Est. completion date: February 2006

Study information

• Verified date: July 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intestinal Neoplasms
• Lymphoma
• Small Intestine Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• etaracizumab

Locations

Country	Name	City	State
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,