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Biochemotherapy With Temozolomide for Metastatic Melanoma

NCT00505635 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-09-24

Study results available
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Summary

The goal of this clinical research study is to learn if treatment with Temodar (temozolomide), Velban (vinblastine), Cisplatin, Proleukin (interleukin-2), Intron-A (interferon alpha), and thalidomide can help to control melanoma that has spread to other parts of the body. The safety of this treatment will also be studied.

Conditions

Interventions

DRUG

Temozolomide

250 mg/m\^2 By Mouth Every 4 Hours x 3 Doses On Day 1

DRUG

Velban

1.5 mg/m\^2 By Vein Over 15-30 Minutes On Days 1-4

DRUG

Cisplatin

20 mg/m\^2 By Vein Over 45-120 Minutes On Days 1-4

DRUG

Interleukin-2

9 MIU/m\^2 By Vein Over 24 Hours x 4 Doses On Days 1-4

DRUG

Intron-A

5 mu/m\^2 Subcutaneously (Under the skin) Daily On Days 1-5

DRUG

Thalidomide

400 mg By Mouth Daily

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
2007-03-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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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 NCT00505635 on ClinicalTrials.gov