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

Stage IV Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003646
• Other study ID #: CDR0000066735
• Secondary ID: VCL-1005-205
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 5, 2011
• Start date: August 1998
• Est. completion date: May 2002

Study information

• Verified date: July 2011
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00416806

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Recurrent Melanoma
• Stage III Melanoma
• Stage IV Melanoma

Intervention

Drug:
• allovectin-7

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Physician Reliance Network, Inc.	Dallas	Texas
United States	Mayo Clinic Cancer Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Country where clinical trial is conducted

United States,