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A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma, Metastatic Melanoma, Malignant Melanoma, Skin Cancer

Thank you

Trial Information

A Phase II Study of High-Dose Allovectin-7® in Patients With Advanced Metastatic Melanoma


Treatment - If you take part in this trial you will be treated for about 10 weeks. You will
receive an injection of Allovectin-7® by needle, directly into one or more selected tumors
once a week for the first six weeks. The injections may be given in a doctor's office.
During a four-week observation period, your disease will be measured to see if the treatment
is working. This will be done by general physical exams and scans (such as X-ray scans).
Patients who show no sign of disease progression may be offered an option to repeat this
treatment course.

Inclusion Criteria


In order to be in this trial, you must meet the enrollment criteria. Below is a list of
some of the enrollment criteria.

- You have been diagnosed with Stage III or Stage IV melanoma

- Your cancer has returned after a prior treatment (e.g. radiation or chemotherapy) or
you refused therapy with standard treatment

- You are able to carry out your normal daily activities

- Your melanoma has not spread to your brain

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

VCL-1005-208

NCT ID:

NCT00044356

Start Date:

February 2001

Completion Date:

September 2004

Related Keywords:

  • Melanoma
  • Metastatic Melanoma
  • Malignant Melanoma
  • Skin Cancer
  • Melanoma
  • Metastatic Melanoma
  • Malignant Melanoma
  • Skin Cancer
  • Tumor
  • Experimental Treatment
  • Clinical Trial
  • Gene Therapy
  • Gene Delivery
  • Gene Transfer
  • Immunotherapy
  • Cancer
  • Neoplasm
  • Lesion
  • Metastasis
  • Cancerous mole
  • Melanoma vaccine
  • Cancer research
  • Cancer cells
  • Allovectin-7®
  • Skin Neoplasms
  • Melanoma

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
MD Anderson Cancer CenterHouston, Texas  77030-4096
Mayo ClinicRochester, Minnesota  55905
University of Colorado Cancer CenterDenver, Colorado  80262
Beth Israel Medical CenterNew York, New York  10003
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Comprehensive Blood and Cancer CenterBakersfield, California  93309
North Memorial Health CareRobbinsdale, Minnesota  55422
Louisiana State University Medical CenterLafayette, Louisiana  70502-4016
University of California, San FranciscoSan Francisco, California  94143
Duke University Medical CenterDurham, North Carolina  27710
University of Arkansas Cancer Research CenterLittle Rock, Arkansas  72205
Oncology Specialists, S.C.Park Ridge, Illinois  60068
Hematology Oncology Associates of BaltimoreBaltimore, Maryland  21236
The Melanoma Center of Saint LouisSaint Louis, Missouri  63131
Cancer Care AllianceSeattle, Washington  98109