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SU5416 in Treating Patients With Metastatic Melanoma That Has Been Previously Treated

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ClinicalTrials.gov Identifier: NCT00006003
Recruitment Status : Terminated (Administratively complete.)
First Posted : January 27, 2003
Last Update Posted : January 24, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
SU5416 may stop the growth of malignant melanoma by stopping blood flow to the tumor. Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic melanoma that has been previously treated

Condition or disease Intervention/treatment Phase
Recurrent Melanoma Stage IV Melanoma Drug: semaxanib Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. Determine the objective response rate and stabilization of disease rates of patients with previously treated metastatic melanoma treated with SU5416.

II. Determine the toxicity of SU5416 in this patient population. III. 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma
Study Start Date : July 2000
Primary Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment (semaxanib)
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.
Drug: semaxanib
Given IV
Other Names:
  • semoxind
  • SU5416
  • Sugen 5416
Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Complete response rate [ Time Frame: Up to 3 years ]
  2. Overall response rate (complete and partial responses) [ Time Frame: Up to 3 years ]
  3. Maintenance of stable disease [ Time Frame: Up to 3 years ]
  4. Treatment toxicity [ Time Frame: Up to 4 weeks post treatment ]
  5. Time to progression [ Time Frame: Up to 3 years ]
    Kaplan-Meier estimates will be calculated.

  6. Survival [ Time Frame: Up to 3 years ]
    Kaplan-Meier estimates will be calculated.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed melanoma with documented metastatic disease

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

    • Greater than 20 mm by conventional techniques ORgreater 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 neurologicallystable, and do not require intravenous antibiotics or anticonvulsants eligibleprovided oral steroids are not required and brain scan (CT or MRI) showsabsence of active or residual disease

    • If neurologic signs or symptoms suggestive of CNS metastasis, negative brain scan required
  • Performance status - WHO 0-2
  • At least 12 weeks
  • WBC at least 3,000/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2.5 times upper limit of normal
  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • 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
  • No pulmonary embolism within past 3 months
  • 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
  • No other concurrent chemotherapy
  • No other concurrent investigational antineoplastic drugs
  • See Disease Characteristics
  • No prior radiotherapy to only site of measurable disease
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy
  • No greater than 1 prior therapy for metastatic disease
  • At least 4 weeks since prior therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006003

United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Thomas Gajewski University of Chicago Comprehensive Cancer Center

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006003     History of Changes
Other Study ID Numbers: NCI-2012-02346
N01CM17102 ( U.S. NIH Grant/Contract )
CDR0000068011 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action