Vaccine Therapy in Treating Patients With Stage IV Melanoma - Full Text View

Sponsored by:	Mannkind Corporation
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00033228

Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma.

Condition	Intervention	Phase
Melanoma (Skin)	Drug: Synchrovax SEM plasmid DNA vaccine	Phase I Phase II

MedlinePlus related topics: Cancer Melanoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

January 2002

Detailed Description:

OBJECTIVES:

Determine the maximum tolerated dose of intranodal Synchrovax SEM plasmid DNA vaccine in patients with stage IV melanoma.
Determine the safety and tolerability of this drug in these patients.
Determine the immunological response, as measured by changes in frequency of T cells specific against vaccine-encoded epitopes before and after treatment, in patients treated with this drug.
Determine the clinical response, as measured by lactic dehydrogenase levels and radiologic assessment of lesions, in patients treated with this drug.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive Synchrovax SEM plasmid DNA vaccine by continuous intranodal infusion on days 1-4. Treatment repeats every 14 days for up to 4 courses in the absence of unacceptable toxicity. Patients with evidence of stable or responding disease are eligible for 4 additional courses of treatment.

Cohorts of 6 patients receive escalating doses of Synchrovax SEM plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 10 days after the last dose of study drug.

PROJECTED ACCRUAL: A total of 6-18 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed stage IV melanoma
Must have tumor tissue available for determining antigen expression
- At least 10% of tumor cells must stain positive for Melan-A/Mart-1 by immunohistochemistry
HLA-A2 positive
No brain metastases unless completely resected or without evidence of disease after treatment

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-1

Life expectancy:

More than 3 months

Hematopoietic:

Absolute neutrophil count at least 1,500/mm3
WBC at least 3,000/mm3
Platelet count at least 75,000/mm3
Hemoglobin at least 9 g/dL

Hepatic:

SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN
Bilirubin no greater than 1.5 times ULN
Hepatitis B surface antigen negative
Hepatitis C antibody negative

Renal:

Creatinine no greater than 1.5 times ULN
Urea no greater than 2.6 times ULN

Other:

Not pregnant, nursing, or planning to become pregnant within 6 months of treatment completion
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No medical, sociological, or psychological impediments that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

At least 4 weeks since prior immunotherapy
At least 4 weeks since prior immunomodulatory drugs
No other concurrent immunotherapy
No concurrent immunomodulatory drugs

Chemotherapy:

At least 4 weeks since prior chemotherapy
No concurrent chemotherapy

Endocrine therapy:

At least 4 weeks since prior systemic corticosteroids
No concurrent systemic corticosteroids

Radiotherapy:

At least 4 weeks since prior radiotherapy
No concurrent radiotherapy

Surgery:

See Disease Characteristics

Other:

At least 4 weeks since prior investigational drugs
No other concurrent investigational drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033228

Locations

United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089
United States, Massachusetts
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Oregon
Earle A. Chiles Research Institute at Providence Portland Medical Center
Portland, Oregon, United States, 97213-2967

Sponsors and Collaborators

Mannkind Corporation

Investigators

Study Chair:

Sabrina Berliner

Mannkind Corporation

More Information

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

Study ID Numbers:	CDR0000069252, CTL-26-35, CTL-BB-IND-10180, NCI-V02-1693
Study First Received:	April 9, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00033228
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IV melanoma
recurrent melanoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Nevus, Pigmented
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Nevus
Recurrence
Neuroendocrine Tumors
Melanoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on January 16, 2009