A Phase I Study Of Medi 522 In Patients With Advanced Tumors
18 Years
N/A
Both
Lymphoma, Small Intestine Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Study Of Medi 522 In Patients With Advanced Tumors
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.
Inclusion 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
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)
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Douglas McNeel, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Federal Government
Study ID:
CDR0000257810
NCT ID:
NCT00049712
Start Date:
October 2002
Completion Date:
Related Keywords:
- Lymphoma
- Small Intestine Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- anaplastic large cell lymphoma
- angioimmunoblastic T-cell lymphoma
- intraocular lymphoma
- primary central nervous system lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult T-cell leukemia/lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- small intestine lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult T-cell leukemia/lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV mycosis fungoides/Sezary syndrome
- unspecified adult solid tumor, protocol specific
- stage IV adult lymphoblastic lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Burkitt lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage III adult T-cell leukemia/lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, Large-Cell, Immunoblastic
- Duodenal Neoplasms
- Ileal Neoplasms
- Jejunal Neoplasms
- Intestinal Neoplasms
Name | Location |
|---|---|
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
