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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Stage IV Melanoma
Stage III Melanoma
Recurrent Melanoma
 Drug: allovectin-7
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vical:
Enrollment: 78
Study Start Date: August 1998
Study Completion Date: May 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003646

Locations
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Texas
Physician Reliance Network, Inc.
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Vical
Investigators
Study Chair: Jennifer Fernandez Vical
  More Information

Responsible Party: Dmitri D. Kharkevitch, MD, PhD, Vical Incorporated
ClinicalTrials.gov Identifier: NCT00003646     History of Changes
Obsolete Identifiers: NCT00416806
Other Study ID Numbers: CDR0000066735  VCL-1005-205 
Study First Received: November 1, 1999
Last Updated: July 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vical:
adult solid tumor
body system/site cancer
cancer
melanoma
recurrent melanoma
 skin tumor
solid tumor
stage III melanoma
stage IV melanoma
stage, melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on September 27, 2016