We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 3, 2004
Last Update Posted: July 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
November 1, 1999
May 3, 2004
July 7, 2011
August 1998
March 2002   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00003646 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
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.

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.


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

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
  • Stage IV Melanoma
  • Stage III Melanoma
  • Recurrent Melanoma
Drug: allovectin-7
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2002
March 2002   (Final data collection date for primary outcome measure)


--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
Not Provided
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
VCL-1005-205 ( Other Identifier: Vical )
Not Provided
Not Provided
Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
Not Provided
Study Chair: Jennifer Fernandez Vical
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP