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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 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

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 AntonioSan Antonio, Texas  78284-7811