Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
This study has been withdrawn prior to enrollment.
Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052403
First received: January 24, 2003
Last updated: January 11, 2007
Last verified: December 2006
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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: | 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 National Cancer Institute (NCI):
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
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052403
Locations
| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
| Study Chair: | Patricia LoRusso, DO | Harper Hospital |
More Information
No publications provided
| 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 11, 2007 |
| 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 May 22, 2013