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Gene Therapy in Treating Patients With Metastatic Melanoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00005943
First received: July 5, 2000
Last updated: May 28, 2013
Last verified: October 2001
  Purpose

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.


Condition Intervention Phase
Melanoma (Skin)
Biological: aldesleukin
Biological: staphylococcal enterotoxin B
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study Using Direct Combination DNA Injections for the Immunotherapy of Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Study Start Date: February 2000
Study Completion Date: September 2001
Primary Completion Date: September 2001 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of liposome complexed staphylococcal enterotoxin B and interleukin-2 plasmid DNA in patients with metastatic melanoma. II. Determine local gene expression in tumor tissues in this patient population treated with this regimen. III. Determine if plasmid DNA can be detected in circulation following intratumoral injection of this regimen in this patient population. IV. Evaluate the antitumor immune responses induced by this treatment regimen in these patients. V. Characterize the clinical response to this treatment regimen in terms of tumor size and histology in these patients. VI. Determine the clinical response to this treatment regimen in terms of complete remission, partial remission, stable disease, and disease progression in these patients.

OUTLINE: This is a dose escalation study. Patients receive intratumoral liposome complexed staphylococcal enterotoxin B (SEB) and interleukin-2 (IL-2) plasmid DNA injections into 1-3 tumor nodules once every 2 weeks. Treatment continues for 6 courses in the absence of disease progression or unacceptable toxicity. Patients with complete regression during therapy may receive additional therapy to previously untreated tumor nodules. Patients with partial response at 4 weeks following the last injection may continue therapy once every 4 weeks until no residual tumor remains. Cohorts of 3 patients each receive escalating doses of SEB and IL-2 plasmid DNA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose limiting toxicities. Patients are followed until death.

PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005943

Locations
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Study Chair: Patrick Walsh, MD University of Colorado, Denver
  More Information

Additional Information:
Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00005943     History of Changes
Other Study ID Numbers: 95-0526.cc
Study First Received: July 5, 2000
Last Updated: May 28, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Colorado, Denver:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on November 20, 2014