Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Stage IV Melanoma; Stage III Melanoma; Recurrent Melanoma	Drug: allovectin-7	Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	78 participants
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
Study Start Date :	August 1998
Actual Primary Completion Date :	March 2002
Actual Study Completion Date :	May 2002

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers:	No

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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
ClinicalTrials.gov Identifier:	NCT00003646 History of Changes
Obsolete Identifiers:	NCT00416806
Other Study ID Numbers:	CDR0000066735; VCL-1005-205 ( Other Identifier: Vical )
First Posted:	May 3, 2004
Last Update Posted:	July 7, 2011
Last Verified:	July 2011

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:

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal	Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas