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SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
This study has been completed.
Study NCT00006003   Information provided by National Cancer Institute (NCI)
First Received: July 5, 2000   Last Updated: July 23, 2008   History of Changes

July 5, 2000
July 23, 2008
August 2000
 
 
 
Complete list of historical versions of study NCT00006003 on ClinicalTrials.gov Archive Site
 
 
 
SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated
A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

RATIONALE: SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated.

OBJECTIVES:

  • Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416.
  • Determine the toxicity of SU5416 in this patient population.
  • Determine the median and overall survival and time to progression in these patients receiving this treatment.

OUTLINE: This is a multicenter study.

Patients receive SU5416 IV over 60 minutes twice weekly for 4 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed weekly for 4 weeks.

PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study within 18-24 months.

Phase II
Interventional
Treatment
Melanoma (Skin)
Drug: semaxanib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma with documented metastatic disease

    • In transit metastases allowed
    • Lesion accessible for biopsy
  • Measurable disease

    • Greater than 20 mm by conventional techniques OR greater than 10 mm by spiral CT
  • Documented progressive disease by radiologic study or physical examination
  • Known history of CNS metastasis who have had treatment, are neurologically stable, and do not require intravenous antibiotics or anticonvulsants eligible provided oral steroids are not required and brain scan (CT or MRI) shows absence of active or residual disease

    • If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • WHO 0-2

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance at least 60 mL/min

Cardiovascular:

  • No uncompensated coronary artery disease
  • No history of myocardial infarction or severe/unstable angina within past 6 months
  • No severe peripheral vascular disease associated with diabetes mellitus
  • No deep venous or arterial thrombosis within past 3 months

Pulmonary:

  • No pulmonary embolism within past 3 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other significant uncontrolled underlying medical or psychiatric illness
  • No serious active infections
  • No other malignancy within past 5 years except for curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No history of severe allergic or anaphylactic reactions to paclitaxel or docetaxel

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No other concurrent chemotherapy
  • No other concurrent investigational antineoplastic drugs

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • No prior radiotherapy to only site of measurable disease
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy

Surgery:

  • Not specified

Other:

  • No greater than 1 prior therapy for metastatic disease
  • At least 4 weeks since prior therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006003
 
CDR0000068011, UCCRC-10395, NCI-48
University of Chicago
National Cancer Institute (NCI)
Study Chair: Thomas F. Gajewski, MD, PhD University of Chicago
National Cancer Institute (NCI)
August 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP