Melanoma Clinical Trial

Vaccine Therapy in Treating Patients With Stage IV Melanoma

Summary

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

19

Study ID:

NCT00033228

Recruitment Status:

Completed

Sponsor:

Mannkind Corporation

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There are 5 Locations for this study

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

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

19

Study ID:

NCT00033228

Recruitment Status:

Completed

Sponsor:


Mannkind Corporation

How clear is this clinincal trial information?

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