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Cisplatin, Temozolomide, Abraxane, With Interleukin-2 and Interferon for Metastatic Melanoma

NCT00970996 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-01-03

No results posted yet for this study

Summary

The goal of this clinical research study is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given in combination with cisplatin, Temodar (temozolomide), interferon alfa-2b, and interleukin-2 (IL-2) to patients with metastatic melanoma.

Primary Objective:

* The primary objective of the Phase I is to determine the toxicity, safety and the maximum tolerated dose maximum tolerated dose of Abraxane in combination with Cisplatin, Temozolomide, interleukin-2 and interferon a2b in patients with metastatic melanoma.

Secondary Objectives:

* To assess responses to the combination.
* To evaluate the duration of response and the overall survival.
* To determine the effectiveness in delaying the appearance of Central Nervous System disease.

Conditions

Interventions

DRUG

Temozolomide

250 mg/m\^2 by mouth on days 1, 2, and 3 of each 21-day cycle.

DRUG

Abraxane

100 mg/m\^2 given in a short intravenous infusion 1 hour after completion of Temozolomide and a 2nd dose of 70 mg/m\^2 given on day 5 of each 21-day cycle.

DRUG

Cisplatin

20 mg/m\^2 intravenously on days 1, 2, 3, and 4 delivered immediately after Abraxane of each 21-day cycle.

BIOLOGICAL

Interleukin-2

9 MIU/m\^2 in a continuous intravenous infusion over 24 hours on days 1, 2, 3, and 4 (total of 96 hours) beginning after completion of Cisplatin of each 21-day cycle.

BIOLOGICAL

Interferon alpha 2b

5 MIU/m\^2 in subcutaneous injection on days 1, 2, 3, 4, and 5 of each 21-day cycle.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Nicholas E. Papadopoulos, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00970996 on ClinicalTrials.gov