Gene Therapy in Treating Patients With Metastatic Melanoma

NCT00005943 | Completed Phase 1 DMC

• 1 other identifier: 95-0526.cc
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Inserting the gene for interleukin-2 into a person's melanoma cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of gene therapy in treating patients who have metastatic melanoma.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma; recurrent melanoma

Interventions

aldesleukin BIOLOGICAL

staphylococcal enterotoxin B BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically confirmed metastatic melanoma unresponsive to standard therapy or for which no curative therapy exists No primary ocular melanoma At least one cutaneous metastatic lesion measuring at least 1 cm in diameter No untreated brain metastases by MRI or CT scan PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-1 Life expectancy: Greater than 2 months Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL No active, acute, or chronic hepatitis Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No unstable angina or complicated cardiovascular disease that would preclude catheterization Immunologic: No active autoimmune disease or infection Peripheral blood mononuclear cell proliferative response to 1 microgram/mL staphylococcal enterotoxin B in vitro, with a stimulation index of at least 5 Other: HIV negative No uncontrolled diabetes mellitus No psychiatric illness that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 weeks since other prior anticancer therapy No concurrent glucocorticosteroids

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado

Denver, Colorado, 80262, United States

Location

Related Publications (1)

• Walsh P, Gonzalez R, Dow S, Elmslie R, Potter T, Glode LM, Baron AE, Balmer C, Easterday K, Allen J, Rosse P. A phase I study using direct combination DNA injections for the immunotherapy of metastatic melanoma. University of Colorado Cancer Center Clinical Trial. Hum Gene Ther. 2000 Jun 10;11(9):1355-68. doi: 10.1089/10430340050032447. No abstract available.

  PMID: 10890744 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

aldesleukin; enterotoxin B, staphylococcal

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Patrick Walsh, MD

  University of Colorado, Denver

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: April 9, 2004
• Study Start: February 1, 2000
• Primary Completion: September 1, 2001
• Study Completion: September 1, 2001
• Last Updated: May 30, 2013

Record last verified: 2001-10

Locations

US (1)