A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Recurrent Melanoma, Stage IV Melanoma

Thank you

Trial Information

A Phase II Trial of SU5416 (NSC #696819) in Patients With Metastatic Melanoma


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Thomas Gajewski

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02346

NCT ID:

NCT00006003

Start Date:

July 2000

Completion Date:

Related Keywords:

  • Recurrent Melanoma
  • Stage IV Melanoma
  • Melanoma

Name

Location
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470