Clinical trial NCT00017316: Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma (Skin)
Keywords: stage IV melanoma
recurrent melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-06-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Eric K. Rowinsky, MD
role: STUDY_CHAIR
References: