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Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma

Phase 3
18 Years
Not Enrolling
Stage IV Melanoma, Stage III Melanoma, Recurrent Melanoma

Thank you

Trial Information

Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma

OBJECTIVES: I. Demonstrate either an improvement in the median time to disease progression
by at least 2 months with no decrease in the rate of objective clinical response OR an
improvement by at least 15% in the rate of objective clinical response with no decrease in
the median time to disease progression in patients with stage III or IV melanoma receiving
dacarbazine with Allovectin-7 when compared with patients receiving dacarbazine alone.

II. Determine the benefits, risks, and side effects of these regimens in this patient

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified
according to sex, age, and spread of disease (cutaneous or nodal vs visceral disease).
Patients are randomized to one of two treatment arms.

Arm I: Patients receive dacarbazine IV over 1 hour on day 0. Arm II: Patients receive
treatment as in arm I. Patients also receive Allovectin-7 intratumorally on days 3 and 10.

Patients with stable or responding disease may receive additional courses every 28 days.

Patients are followed every 4 months.


A total of 280 patients (140 in each arm) will be accrued for this study.

Inclusion Criteria


--Disease Characteristics--

- Histologically confirmed stage III or IV melanoma 1 or more metastatic tumors for
which surgery is not deemed to be a curative option

- Dacarbazine is indicated as first line chemotherapy

- At least 1 measurable tumor at least 1 cm2 but no greater than 100 cm2

- No history of brain metastases

--Prior/Concurrent Therapy--

- Biologic therapy: At least 4 weeks since prior biologic therapy

- Chemotherapy: See Disease Characteristics; No 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 experimental therapy

--Patient Characteristics--

- Age: 18 and over

- Performance status: Karnofsky 80-100%

- Life expectancy: At least 24 weeks

- 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 (ULN); PT/PTT normal; Albumin normal; LDH no greater than 2 times ULN

- 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; Not pregnant or nursing; 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 within the past 5 years except skin cancer or stage 0-II
cervical cancer; No significant psychiatric disorders

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Cherie Smith

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

July 1998

Completion Date:

September 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



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