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Recurrent MelanomaPhase 2NCT00006003

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

A Phase 2 study testing semaxanib and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma, Stage IV Melanoma
What is being tested?
semaxanib and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Jul 2000to Jul 2003
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 36Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: 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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
semaxanib, laboratory biomarker analysis
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • semaxanibDrug

    Also called semoxind, SU5416, Sugen 5416

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00006003
Study groupRoleWhat they receive
Treatment (semaxanib)ExperimentalPatients 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.
Receives: Drug: semaxanib; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response rate

    Measured: Up to 3 years

  2. Overall response rate (complete and partial responses)

    Measured: Up to 3 years

  3. Maintenance of stable disease

    Measured: Up to 3 years

  4. Treatment toxicity

    Measured: Up to 4 weeks post treatment

  5. Time to progression

    Kaplan-Meier estimates will be calculated.

    Measured: Up to 3 years

  6. Survival

    Kaplan-Meier estimates will be calculated.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 2000
  3. Primary completionJul 2003

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006003
Sponsor's protocol ID
NCI-2012-02346
Other IDs
10395, N01CM17102, CDR0000068011
Status last verified
Jan 2013
First submitted
5 Jul 2000
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing semaxanib and laboratory biomarker analysis in people with Recurrent Melanoma and Stage IV Melanoma, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response rate (time frame: Up to 3 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006003.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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