Trial | NCT00003647  Report issue

Title

Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma
Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    None
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Injecting allovectin-7 into a person's melanoma cells may make the body build an immune response that will kill tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of dacarbazine with or without immunotherapy in treating patients who have stage III or stage IV 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 population.

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.

PROJECTED ACCRUAL:

A total of 280 patients (140 in each arm) will be accrued for this study.
Study Started
Jul 31
1998
Study Completion
Sep 30
2002
Last Update
Jul 25
2008
Estimate

Drug allovectin-7

Drug allovectin-7/dacarbazine

Drug dacarbazine

Criteria 

PROTOCOL ENTRY 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
No Results Posted