Know Cancer

forgot password

Phase II Study of Allovectin-7 as an Immunotherapeutic Agent in Patients With Stages III and IV Melanoma

Phase 2
18 Years
Not Enrolling
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma

Thank you

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

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


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

Inclusion 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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Jennifer Fernandez

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




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



Roswell Park Cancer Institute Buffalo, New York  14263
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Physician Reliance Network, Inc. Dallas, Texas  75246