Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma - Full Text View

Sponsor:	Vical
Information provided by:	Vical
ClinicalTrials.gov Identifier:	NCT00003646

Purpose

RATIONALE: Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have stage III or stage IV melanoma that has not responded to previous treatment.

Condition	Intervention	Phase
Stage IV Melanoma Stage III Melanoma Recurrent Melanoma	Drug: allovectin-7	Phase II

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Allovectin 7

U.S. FDA Resources

Further study details as provided by Vical:

Study Start Date:

August 1998

Detailed Description:

OBJECTIVES: I. Demonstrate an objective clinical response (partial or complete) with a median duration of at least 4 months in 15% of patients with stage III or IV melanoma treated with Allovectin-7. Allovectin-7 is a direct gene transfer immunotherapeutic agent.

II. Determine the benefits, risks, and side effects of Allovectin-7 in this patient population.

PROTOCOL OUTLINE: This is a multicenter study. Patients receive an intratumoral injection of Allovectin-7 once weekly for 6 weeks. At week 9, a complete disease status assessment is performed. Patients with stable or responding disease may receive additional courses of 6 injections.

PROJECTED ACCRUAL:

A total of 70 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:

18 Years and older

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed melanoma; Stage III with locoregional disease, in transit metastasis, or nodal disease OR Stage IV metastatic disease in skin, subcutaneous tissue, lymph node(s), and/or lung
At least 1 metastasis for which surgery is not deemed to be a curative option
Relapsed from or has not responded to frontline chemotherapy or biotherapy
At least 1 measurable tumor at least 1 cm by 1 cm, but less than 5 cm by 5 cm
No history of brain metastases or visceral metastases other than lung metastases

--Prior/Concurrent Therapy--

Biologic therapy: See Disease Characteristics; At least 4 weeks since prior biologic therapy
Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy
Endocrine therapy: No concurrent immunosuppressive drugs
Radiotherapy: At least 4 weeks since prior radiotherapy
Surgery: At least 2 weeks since prior major surgery
Other: No other concurrent anticancer drug therapy, or any other experimental therapy

--Patient Characteristics--

Age: 18 and over
Performance status: Karnofsky 80-100%
Life expectancy: At least 6 months
Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL
Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT less than 3 times upper limit of normal; PT/PTT normal LDH and albumin normal
Renal: Creatinine no greater than 2.0 mg/dL
Cardiovascular: No uncontrolled hypertension; No New York Heart Association class III or IV disease
Other: HIV negative; Negative pregnancy test; Fertile patients must use effective contraception; No active autoimmune disease; No active infection requiring parenteral antibiotics; No uncontrolled diabetes mellitus; No other prior malignancy in the past 5 years except skin cancer or stage 0-II cervical cancer; No significant psychiatric disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003646

Locations

United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Texas
Physician Reliance Network, Inc.
Dallas, Texas, United States, 75246

Sponsors and Collaborators

Vical

Investigators

Study Chair:

Jennifer Fernandez

Vical

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066735, VCL-1005-205
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003646 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vical:

adult solid tumor
body system/site cancer
cancer
melanoma
recurrent melanoma

skin tumor
solid tumor
stage III melanoma
stage IV melanoma
stage, melanoma

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Nevi and Melanomas
Neuroendocrine Tumors
Melanoma

ClinicalTrials.gov processed this record on March 18, 2010