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

This study has been completed.
Sponsor:
Information provided by:
Vical
ClinicalTrials.gov Identifier:
NCT00003646
First received: November 1, 1999
Last updated: July 5, 2011
Last verified: July 2011

November 1, 1999
July 5, 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.

PROJECTED ACCRUAL:

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

Interventional
Phase 2
Masking: 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.
 
Completed
78
May 2002
March 2002   (final data collection date for primary outcome measure)

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
Not Provided
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003646
CDR0000066735, VCL-1005-205
Yes
Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
Vical
Not Provided
Study Chair: Jennifer Fernandez Vical
Vical
July 2011

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