Chemotherapy With or Without Immunotherapy in Treating Patients With Stage III or Stage IV Melanoma - Full Text View

Sponsor:	Vical
Information provided by:	Vical
ClinicalTrials.gov Identifier:	NCT00003647

Purpose

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.

Condition	Intervention	Phase
Stage IV Melanoma Stage III Melanoma Recurrent Melanoma	Drug: allovectin-7 Drug: allovectin-7/dacarbazine Drug: dacarbazine	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Phase III Randomized Study of Dacarbazine With or Without Allovectin-7 in Patients With Metastatic Melanoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma

Drug Information available for: Allovectin 7 Dacarbazine

U.S. FDA Resources

Further study details as provided by Vical:

Study Start Date:	July 1998
Study Completion Date:	September 2002

Detailed Description:

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.

Eligibility

Ages Eligible for Study:

18 Years and older

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003647

Show 44 Study Locations

Sponsors and Collaborators

Vical

Investigators

Study Chair:

Cherie Smith

Vical

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066736, VCL-1005-301
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00003647 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vical:

adult solid tumor
body system/site cancer
cancer
melanoma
recurrent melanoma

skin tumor
solid tumor
stage III melanoma
stage IV melanoma
stage, melanoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Dacarbazine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Pharmacologic Actions
Melanoma
Neuroendocrine Tumors

Neuroectodermal Tumors
Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on November 27, 2009