Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor
18 Years
N/A
Both
Colorectal Cancer, Head and Neck Cancer, Kidney Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Trial of NGR-TNF Administered Every 3 Weeks as a 1 Hour Intravenous Infusion in Patients With Solid Tumor
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Dose-limiting toxicity and maximum tolerated dose as measured by CTC v 3.0
Safety Issue:
Yes
Principal Investigator
Cornelis J. A. Punt, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitair Medisch Centrum St. Radboud - Nijmegen
Authority:
United States: Federal Government
Study ID:
EORTC-16041
NCT ID:
NCT00098943
Start Date:
September 2004
Completion Date:
Related Keywords:
- Colorectal Cancer
- Head and Neck Cancer
- Kidney Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
- stage IV renal cell cancer
- recurrent renal cell cancer
- stage IV colon cancer
- recurrent colon cancer
- anaplastic thyroid cancer
- insular thyroid cancer
- thyroid gland medullary carcinoma
- stage IV follicular thyroid cancer
- stage IV papillary thyroid cancer
- recurrent thyroid cancer
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent verrucous carcinoma of the larynx
- recurrent verrucous carcinoma of the oral cavity
- stage IV verrucous carcinoma of the oral cavity
- stage IV verrucous carcinoma of the larynx
- recurrent adenoid cystic carcinoma of the oral cavity
- stage IV adenoid cystic carcinoma of the oral cavity
- recurrent basal cell carcinoma of the lip
- stage IV basal cell carcinoma of the lip
- recurrent mucoepidermoid carcinoma of the oral cavity
- stage IV mucoepidermoid carcinoma of the oral cavity
- recurrent lymphoepithelioma of the nasopharynx
- recurrent lymphoepithelioma of the oropharynx
- stage IV lymphoepithelioma of the nasopharynx
- stage IV lymphoepithelioma of the oropharynx
- recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
- stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
- recurrent inverted papilloma of the paranasal sinus and nasal cavity
- recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
- stage IV inverted papilloma of the paranasal sinus and nasal cavity
- stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
- metastatic parathyroid cancer
- recurrent parathyroid cancer
- recurrent salivary gland cancer
- stage IV salivary gland cancer
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Colorectal Neoplasms
- Head and Neck Neoplasms
- Neoplasms
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