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An Evaluation of the Pharmacokinetic Profile of VSLI (Vincristine Sulfate Liposome Injection, 0.16 mg/mL) in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases


Phase 1
18 Years
N/A
Not Enrolling
Both
Malignant Melanoma

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Trial Information

An Evaluation of the Pharmacokinetic Profile of VSLI (Vincristine Sulfate Liposome Injection, 0.16 mg/mL) in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases


OBJECTIVES:

Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with
malignant melanoma and hepatic dysfunction secondary to metastases.

Secondary: To assess the safety and antitumor activity of VSLI in this population.


Inclusion Criteria:



- Patients must have histologically confirmed, surgically nonresectable Stage III or IV
metastatic cutaneous, mucosal, or choroidal melanoma, and not be eligible for a
treatment protocol of a higher priority.

- Patients must have secondary tumor involvement of the liver confirmed by CT scan and
a bilirubin level of 1.6-3.0 mg/dL (National Cancer Institute, Common Terminology
Criteria for Adverse Events Grade 2) (MD Anderson Cancer Center normal range is 0-1.0
mg/dL).

- Patients must have bidimensionally measurable disease.

- Patients with nonchoroidal melanoma must have received prior chemotherapy for
metastatic disease with cytotoxic or biological drugs. Patients with choroidal
melanoma may or may not have received prior chemotherapy for metastatic disease with
cytotoxic or biological drugs.

- Patients must have a Performance Status of 0, 1, 2, or 3 (Zubrod Scale).

- Patients must have recovered from the adverse effects of prior chemotherapy
(including cytotoxic agents and biological response modifiers), and/or irradiation
therapy.

- Patients must have an absolute neutrophil count ≥1.0 x 10*9/L and a platelet count of
≥100 x 10*9/L.

- Patients must have adequate renal function demonstrated by a creatinine level of ≤2.0
mg/dL.

- Patients must have a life expectancy of >8 weeks.

- Patients must provide a signed informed consent document indicating that they are
aware of the investigational nature of this study in keeping with the policies of the
hospital.

Exclusion Criteria:

- Patients treated with radiotherapy, chemotherapy, immunotherapy, vaccine treatment
and/or alternative anticancer treatments (including investigational drugs) within 3
weeks prior to study enrollment.

- Patients treated with hepatic chemo-embolization within 4 weeks prior to study
enrollment.

- Patients with severe hepatic impairment demonstrated by plasma ammonia levels >105
mMol/L or serum albumin <2.0 g/dL or serum bilirubin >3.0 mg/dL.

- Patients with serious intercurrent illness.

- Patients who have had major surgery within 4 weeks of enrollment.

- Patients with advanced symptomatic central nervous system (CNS) involvement by
melanoma and those on phenytoin or requiring steroids for brain metastases, spinal
cord compression, or meningeal "carcinomatosis".Patients with asymptomatic and stable
metastatic CNS disease can be enrolled.

- Patients receiving treatment with phenytoin and/or corticosteroids within 1 week of
enrollment. Patients must remain off of these medications for the duration of the
treatment phase of the study.

- Patients with a history of neurological disorders unrelated to chemotherapy
(including familial neurological diseases and acquired demyelinating disorders).

- Patients with Grade 3 or greater sensory, motor or autonomic neuropathy at screening
from any cause.

- Patients receiving treatment with drugs known to inhibit or induce hepatic drug
metabolism by cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of
study enrollment. Patients must remain off of these drugs until the collection of the
Cycle 4 pretreatment PK sample.

- Patients with past or current history of liver parenchymal or hepatobiliary disease
unrelated to cancer (including but not limited to conditions such as liver cirrhosis,
acute/chronic hepatitis, ascending cholangitis, etc).

- Patients who are pregnant or lactating. Females of childbearing potential must have a
negative urine or blood pregnancy test at screening. Both men and women must be
practicing an adequate method of birth control for the duration of the study.
Acceptable methods of birth control include use of an intrauterine device (IUD), oral
contraceptive pills, implanted, transdermal, or injected contraceptives, barrier
methods with spermicide, and abstinence.

- Patients who are unable to return for follow up re-evaluation and assessment of
response to VSLI.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

T 1/2

Outcome Description:

The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.

Outcome Time Frame:

cycle 1 day 1

Safety Issue:

No

Principal Investigator

Agop Bedikian, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MD Anderson Cancer Center, Dept of Melanoma

Authority:

United States: Food and Drug Administration

Study ID:

VSLI-12-HEPHARM

NCT ID:

NCT00145041

Start Date:

February 2005

Completion Date:

November 2007

Related Keywords:

  • Malignant Melanoma
  • Melanoma
  • Liver Diseases

Name

Location

University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030