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

NCT ID: NCT00003646

Last Updated: 2011-07-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2002-05-31

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.

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.

Conditions

Stage IV Melanoma; Stage III Melanoma; Recurrent Melanoma

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

allovectin-7

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Accepts Healthy Volunteers: No

Sponsors

Vical

INDUSTRY

Sponsor Role: lead

Responsible Party

Vical Incorporated

Principal Investigators

Jennifer Fernandez

Role: STUDY_CHAIR

Vical

Locations

Mayo Clinic Cancer Center

Rochester, Minnesota, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Physician Reliance Network, Inc.

Dallas, Texas, United States

Countries

United States

Other Identifiers

VCL-1005-205

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000066735

Identifier Type: -

Identifier Source: org_study_id

NCT00416806

Identifier Type: -

Identifier Source: nct_alias