Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Advanced Solid Tumors
Phase I Study of Monoclonal Antibody Anti-Anb3 Integrin in Patients With Advanced Solid Tumors
NCT00052403CI-TRIAL-00013477withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was not successful at recruiting particpants
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| antiangiogenesis therapy | Procedure | — | UNRESOLVED |
| antibody therapy | Procedure | — | UNRESOLVED |
| anti-cytokine therapy | Procedure | — | UNRESOLVED |
| biological response modifier therapy | Procedure | — | UNRESOLVED |
| growth factor antagonist therapy | Procedure | — | UNRESOLVED |
| monoclonal antibody anti-anb3 integrin | Drug | — | UNRESOLVED |
| monoclonal antibody therapy | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 * Eastern Cooperative Oncology Group (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 * alanine aminotransferase test (ALT) and Aspartate Aminotransferase (AST) no greater than 2.5 times upper limit of normal (ULN) * Prothrombin time (PT)/ partial thromboplastin time (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 Exclusion Criteria 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
References
Publications (0)
Data not yet available
No reference posted for this study.