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
  Purpose

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 Intervention Phase
Recurrent Melanoma
Stage IV Melanoma
Drug: semaxanib
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: July 2000
Primary Completion Date: July 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006003

Locations
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
Sponsors and Collaborators
Investigators
Principal Investigator: Thomas Gajewski University of Chicago Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006003     History of Changes
Other Study ID Numbers: NCI-2012-02346, 10395, N01CM17102, CDR0000068011
Study First Received: July 5, 2000
Last Updated: January 23, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
SU 5416
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 08, 2014