A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients
18 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Phase I/II Pilot Study Of Intranodal Delivery Of A Plasmid DNA (Synchrovax SEM Vaccine) In Stage IV Melanoma Patients
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.
Principal Investigator
Chief Scientific Officer
Investigator Role:
Study Chair
Investigator Affiliation:
Mannkind Corporation
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000069252
NCT ID:
NCT00033228
Start Date:
January 2002
Completion Date:
April 2003
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
| Cancer Research Center at Boston Medical Center | Boston, Massachusetts 02118 |
| Earle A. Chiles Research Institute at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
