Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00017316
First received: June 6, 2001
Last updated: February 8, 2013
Last verified: August 2002

June 6, 2001
February 8, 2013
March 2001
September 2003   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00017316 on ClinicalTrials.gov Archive Site
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Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma
A Phase II, Pharmacologic and Biologic Study of Escalating Doses of Thalidomide (NSC #66847) Administered Orally Once a Day in Combination With a Fixed Dose of SU5416 (NSC #696819) in Patients With Metastatic Melanoma

Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating patients who have metastatic melanoma. Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.

OBJECTIVES:

I. Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma.

II. Determine the quantitative and qualitative toxic effects of this regimen in these patients.

III. Evaluate the pharmacokinetics of this regimen in these patients. IV. Determine the complete and partial responses and response duration in patients treated with this regimen.

V. Assess disease-free survival at 6 months of patients treated with this regimen.

OUTLINE:

Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma (Skin)
  • Drug: semaxanib
  • Drug: thalidomide
Experimental: Arm I
Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions:
  • Drug: semaxanib
  • Drug: thalidomide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
Not Provided
September 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed metastatic melanoma
  • Bidimensionally measurable disease by MRI, CT scan, or chest x-ray
  • No active brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • More than 12 weeks

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8.5 g/dL

Hepatic:

  • PT/PTT normal
  • Bilirubin no greater than 1.5 mg/dL
  • SGOT/SGPT no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No uncompensated coronary artery disease by electrocardiogram or physical exam
  • No myocardial infarction or severe or unstable angina within the past 6 months
  • No deep venous thrombosis within the past 3 months
  • No arterial thrombosis within the past 6 months

Pulmonary:

  • No pulmonary embolism within the past 6 months

Other:

  • HIV negative
  • No active infection
  • No medical, psychological, or social problem that would preclude study participation
  • No history of gastrointestinal disorder that would interfere with absorption or swallowing of study medication
  • No emotional disorder or substance abuse
  • No diabetes mellitus with severe peripheral vascular disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 forms of effective contraception for 4 weeks before, during, and for 4 weeks after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No more than 1 prior biologic regimen
  • No concurrent biologic response modifiers
  • No concurrent hematopoietic growth factor support
  • Concurrent epoetin alfa allowed

Chemotherapy:

  • No concurrent cytotoxic agents

Endocrine therapy:

  • No concurrent anticancer hormonal therapy except megestrol acetate for appetite stimulation

Radiotherapy:

  • No prior large field radiotherapy to more than 20% total bone marrow
  • No concurrent radiotherapy

Surgery:

  • At least 14 days since major surgery
  • No prior major upper gastrointestinal surgery

Other:

  • No other concurrent investigational therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00017316
CDR0000068677, UTHSC-IDD-99-27, SACI-IDD-99-27, NCI-66
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Eric K. Rowinsky, MD The University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
August 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP