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 the side effects and best dose of NGR-TNF in treating patients with advanced solid tumors.
Who can participate
Age range18 Years
SexALL
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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
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What they're measuring
1
Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0
Trial details
NCT IDNCT00098943
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC