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

NCT00006003 | Terminated Phase 2

• 4 other identifiers: NCI-2012-0234610395N01CM17102CDR0000068011
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Recurrent Melanoma; Stage IV Melanoma

Outcome Measures

Primary Outcomes (6)

• Complete response rate

  Up to 3 years

• Overall response rate (complete and partial responses)

  Up to 3 years

• Maintenance of stable disease

  Up to 3 years

• Treatment toxicity

  Up to 4 weeks post treatment

• Time to progression

  Kaplan-Meier estimates will be calculated.

  Up to 3 years

• Survival

  Kaplan-Meier estimates will be calculated.

  Up to 3 years

Study Arms (1)

Treatment (semaxanib)

EXPERIMENTAL

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; Other: laboratory biomarker analysis

Interventions

semaxanib DRUG

Given IV

Also known as: semoxind, SU5416, Sugen 5416

Treatment (semaxanib)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (semaxanib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637-1470, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Semaxinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas Gajewski

  University of Chicago Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: January 27, 2003
• Study Start: July 1, 2000
• Primary Completion: July 1, 2003
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)