Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
18 Years
N/A
Both
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma
Trial Information
Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Jennifer Fernandez
Investigator Role:
Study Chair
Investigator Affiliation:
Vical
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000066735
NCT ID:
NCT00003646
Start Date:
August 1998
Completion Date:
May 2002
Related Keywords:
- Stage IV Melanoma
- Stage III Melanoma
- Recurrent Melanoma
- adult solid tumor
- body system/site cancer
- cancer
- melanoma
- recurrent melanoma
- skin tumor
- solid tumor
- stage III melanoma
- stage IV melanoma
- stage, melanoma
- Melanoma
Name | Location |
|---|---|
| Roswell Park Cancer Institute | Buffalo, New York 14263 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| Physician Reliance Network, Inc. | Dallas, Texas 75246 |
