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A Phase I Pharmacodynamic Trial of SU5416 (NSC 696819)


Phase 1
18 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Pharmacodynamic Trial of SU5416 (NSC 696819)


OBJECTIVES: I. Determine the maximum target-inhibiting dose of SU5416 in patients with
advanced solid tumors. II. Determine the relationship between dose or plasma levels and the
clinical safety profile and antitumor effects of this treatment regimen in terms of
objective response, stabilization of disease, or progression-free survival in this patient
population. III. Evaluate the relationship between dose or plasma levels of SU5416
concentrations and the ability of this treatment regimen to reduce microvessel density and
induce apoptosis of endothelial and tumor cells in this patient population. IV. Determine
prognostic and surrogate serologic markers in these patients treated with this regimen. V.
Determine if pre and posttreatment plasma and serum levels of angiogenic growth factors,
basic fibroblast growth factor, and vascular endothelial cell growth factor are prognostic
in predicting patient response to this regimen. VI. Determine if elevated plasma levels of
endothelial cell specific proteins reflective of SU5416-induced endothelial damage and/or
apoptosis are useful surrogate markers in assessing response to this treatment regimen in
these patients.

OUTLINE: This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice
weekly for 4 weeks. Treatment continues in the absence of disease progression or
unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until
the maximum target-inhibiting dose (MTID) is determined. The MTID is defined as the dose at
which patients experience no greater than grade 1 toxicity. Patients are followed every 3
months.

PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed solid tumors not amenable to
conventional therapy At least 2 distinct lesions of metastatic or primary tumor of at
least 1-2 cm OR Single lesion if large enough for both biopsy and MRI flow studies No
brain metastases or primary brain tumors

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hemoglobin greater than 9.0 g/dL Hepatic: Bilirubin
normal PT normal OR INR less than 1.1 PTT normal Renal: Creatinine less than 1.5 mg/dL
AND/OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart
Association class III or IV heart disease No uncompensated coronary artery disease on
electrocardiogram or physical exam No myocardial infarction or severe or unstable angina
within the past 6 months No severe peripheral vascular disease associated with diabetes
mellitus No deep vein thrombosis or arterial thrombosis within the past 3 months
Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant or nursing
Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
and recovered Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for
mitomycin or nitrosoureas) and recovered Endocrine therapy: At least 3 weeks since prior
hormonal therapy and recovered Radiotherapy: At least 4 weeks since prior large field
radiotherapy and recovered Surgery: Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors.

Outcome Time Frame:

1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients followed every 3 months.

Safety Issue:

Yes

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ireland Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU2Y99

NCT ID:

NCT00005642

Start Date:

May 2000

Completion Date:

November 2005

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065