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

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006003
First received: July 5, 2000
Last updated: January 23, 2013
Last verified: January 2013

July 5, 2000
January 23, 2013
July 2000
July 2003   (final data collection date for primary outcome measure)
  • Complete response rate [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Overall response rate (complete and partial responses) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Maintenance of stable disease [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Treatment toxicity [ Time Frame: Up to 4 weeks post treatment ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be calculated.
  • Survival [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    Kaplan-Meier estimates will be calculated.
Not Provided
Complete list of historical versions of study NCT00006003 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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

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

PRIMARY OBJECTIVES:

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Melanoma
  • Stage IV Melanoma
  • Drug: semaxanib
    Given IV
    Other Names:
    • semoxind
    • SU5416
    • Sugen 5416
  • Other: laboratory biomarker analysis
    Correlative studies
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.
Interventions:
  • Drug: semaxanib
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
Not Provided
July 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006003
NCI-2012-02346, 10395, N01CM17102, CDR0000068011
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Thomas Gajewski University of Chicago Comprehensive Cancer Center
National Cancer Institute (NCI)
January 2013

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