Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI WCCC-CO-01905 NCI-5497, NCT00049712, 5497

Objectives

1. 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.
2. Determine the safety and tolerability of this drug in these patients.
3. Demonstrate significant binding of this drug to its molecular target in vivo in these patients.
4. Determine the effects of this drug on angiogenesis in these patients.
5. Determine antitumor activity of this drug by measuring tumor size and glucose uptake in these patients.
6. Determine the pharmacokinetics of this drug in these patients.
7. Determine a recommended phase II dose of this drug based on either the MTD or the optimal biologic response in these patients.

Entry Criteria

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

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)

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• More than 12 weeks

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

Approximately 6-30 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Douglas McNeel, MD, PhD, Protocol chair		Ph: 608-265-8090; 800-622-8922

Registry Information
Official Title		A Phase I Study Of Medi 522 In Patients With Advanced Tumors
Trial Start Date		2002-10-21
Registered in ClinicalTrials.gov		NCT00049712
Date Submitted to PDQ		2002-09-05
Information Last Verified		2004-07-26
NCI Grant/Contract Number		CA62491, CA14520

Back to Top