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
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Eric K. Rowinsky, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas Health Science Center at San Antonio
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000068677
NCT ID:
NCT00017316
Start Date:
March 2001
Completion Date:
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio, Texas 78284-7811 |
