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

Primary Purpose

Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
allovectin-7
Sponsored by
Vical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage IV Melanoma focused on measuring adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Does not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Cancer Center
  • Roswell Park Cancer Institute
  • Physician Reliance Network, Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 5, 2011
Sponsor
Vical
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1. Study Identification

Unique Protocol Identification Number
NCT00003646
Brief Title
Gene Therapy in Treating Patients With Stage III or Stage IV Melanoma
Official Title
Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
March 2002 (Actual)
Study Completion Date
May 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
Keywords
adult solid tumor, body system/site cancer, cancer, melanoma, recurrent melanoma, skin tumor, solid tumor, stage III melanoma, stage IV melanoma, stage, melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
allovectin-7

10. Eligibility

Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Fernandez
Organizational Affiliation
Vical
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Physician Reliance Network, Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

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

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