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

National Cancer Institute (NCI)

Status and phase: Terminated; Phase 2

Conditions: Recurrent Melanoma; Stage IV Melanoma

Treatments: Drug: semaxanib; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: NIH

Identifiers

NCT00006003

N01CM17102 (U.S. NIH Grant/Contract)

10395

NCI-2012-02346

CDR0000068011 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Treatment (semaxanib)

Experimental group

Description:

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.

Treatment:

Other: laboratory biomarker analysis

Drug: semaxanib