Status:
COMPLETED
NGR-TNF in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Colorectal Cancer
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Targeted therapy with tumor necrosis factor combined with a fusion protein may stop the growth of solid tumors by stopping blood flow to the tumor. PURPOSE: This phase I trial is studying ...
Detailed Description
OBJECTIVES: Primary * Determine the dose-limiting toxicity and maximum tolerated dose of tumor vasculature-targeted tumor necrosis factor alpha (NGR-TNF) in patients with advanced solid tumors. * De...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of advanced solid tumor not amenable to any clinical improvement by current standard treatments
- Preferably tumors well known to be very angiogenic (e.g., renal, colon, thyroid, and head and neck cancers)
- No clinical signs of CNS involvement
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- ECOG 0-2 OR
- WHO 0-2
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin \< 1.5 times upper limit of normal (ULN)
- AST and/or ALT \< 2.5 times ULN (5 times ULN in the presence of liver metastases)
- Renal
- Creatinine \< 1.5 times ULN
- Cardiovascular
- Cardiac function normal
- No uncontrolled hypertension
- No condition in which hypovolemia and its consequences (e.g., increased stroke volume, elevated blood pressure) or hemodilution could represent a risk to the patient
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No active or uncontrolled systemic infection
- No other uncontrolled disease, serious illness, or medical condition that would preclude study participation
- No known hypersensitivity/allergic reaction to human albumin preparations or any of the excipients
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- At least 28 days since prior immunotherapy
- Chemotherapy
- At least 28 days since prior chemotherapy and recovered
- Endocrine therapy
- At least 28 days since prior hormonal therapy
- Radiotherapy
- At least 28 days since prior radiotherapy and recovered
- No prior radiotherapy to \> 25% of bone marrow reserve
- Surgery
- More than 2 weeks since prior surgery
- Other
- No other concurrent anticancer therapy
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00098943
Start Date
September 1 2004
Last Update
September 24 2012
Active Locations (2)
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1
University Medical Center Hamburg - Eppendorf
Hamburg, Germany, D-20246
2
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, Netherlands, NL-6500 HB