Patient case: 32-year-old female with inflammatory myofibroblastic tumor; genetic feature: RANBP2-ALK fusion

Clinical trial: NGR-TNF in Treating Patients With Advanced Solid Tumors

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 the side effects and best dose of NGR-TNF in treating patients with advanced solid tumors.

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.
  -  Determine the recommended phase II dose of this drug in these patients.
  Secondary
  -  Determine the mechanism of action of this drug in these patients.
  -  Determine response in patients treated with this drug.
  OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.
  Patients receive tumor vasculature-targeted tumor necrosis factor alpha (NGR-TNF) IV over 1 hour on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
  Cohorts of 1-6 patients receive escalating doses of NGR-TNF 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. Up to 12 patients receive treatment at the MTD.
  Patients are followed every 8 weeks until disease progression or the start of a new anticancer treatment.
  PROJECTED ACCRUAL: A total of 1-30 patients will be accrued for this study.

Eligibility: 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

Relevance to patient case: not relevant