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

Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

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.

Study Overview

• Status: Completed
• Conditions: Recurrent Melanoma; Stage IV Melanoma; Stage III Melanoma
• Intervention / Treatment: Drug: allovectin-7

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 Type: Interventional
• Enrollment (Actual): 78
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Masking: NONE

Collaborators and Investigators

• Sponsor: Vical
• Investigators: Study Chair: Jennifer Fernandez, Vical

Study record dates

Study Major Dates

• Study Start: August 1, 1998
• Primary Completion (ACTUAL): March 1, 2002
• Study Completion (ACTUAL): May 1, 2002

Study Registration Dates

• First Submitted: November 1, 1999
• First Submitted That Met QC Criteria: April 30, 2004
• First Posted (ESTIMATE): May 3, 2004

Study Record Updates

• Last Update Posted (ESTIMATE): July 7, 2011
• Last Update Submitted That Met QC Criteria: July 5, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: cancer; recurrent melanoma; stage IV melanoma; adult solid tumor; solid tumor; melanoma; body system/site cancer; stage III melanoma; skin tumor; stage, melanoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: CDR0000066735; VCL-1005-205 (OTHER: Vical)