Vaccine Therapy in Treating Patients With Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00023647
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : July 10, 2012
Information provided by (Responsible Party):
Mannkind Corporation

Brief 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 trial to study the effectiveness of vaccine therapy given directly into a lymph node in treating patients who have stage IV melanoma.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Biological: Synchrotope TA2M Phase 1

Detailed Description:

OBJECTIVES: I. Determine the safety and tolerability of intranodal Synchrotope TA2M plasmid DNA vaccine in patients with stage IV melanoma. II. Determine the immune response of patients treated with this vaccine. III. Determine the clinical response of patients treated with this vaccine.

OUTLINE: This is dose-escalation, multicenter study. Patients receive Synchrotope TA2M plasmid DNA vaccine intranodally continuously over 96 hours beginning on days 0, 14, 28, and 42. Treatment continues for up to 2 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 8 patients receive escalating doses of Synchrotope TA2M plasmid DNA vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 8 patients experience dose-limiting toxicity.

PROJECTED ACCRUAL: Approximately 16-24 patients will be accrued for this study within 12 months.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose-Ranging Safety Study Using Intranodal Delivery of a Plasmid DNA (Synchrotope TA2M) in Adult Stage IV Melanoma Patients
Study Start Date : July 2000
Actual Primary Completion Date : April 2002
Actual Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: Synchrotope TA2M, 800 micrograms
Tyrosinase peptides, 800 micrograms
Biological: Synchrotope TA2M
Cancer Vaccine, Immunotherapy

Experimental: Synchrotope TA2M, 200 micrograms
Tyrosinase peptides, 200 micrograms
Biological: Synchrotope TA2M
Cancer Vaccine, Immunotherapy

Experimental: Synchrotope TA2M, 400 micrograms
Tyrosinase peptides, 400 micrograms
Biological: Synchrotope TA2M
Cancer Vaccine, Immunotherapy

Primary Outcome Measures :
  1. Frequency of adverse events assessed by complete blood count, blood chemistry, polymerase chain reaction, physical examination and urinalysis [ Time Frame: Individual 96-hour infusion periods on days 0, 14, 28 and 42 and on day 56 ]

Secondary Outcome Measures :
  1. Change in magnitude of antigen-specific cytotoxic t-lymphocyte in peripheral blood mononuclear cells [ Time Frame: Day 0 (pre-study), last day of individual 96-hour infusion periods (days 4, 17, 31 and 45) and on day 56 ]
  2. Assessment of delayed-type hypersensitivity to intradermal injections 24 hours after injection [ Time Frame: Days 1, 29 and 57 ]
  3. Change in size of target lesions by x-ray computed tomography before (day 0) and after (day 56)treatment [ Time Frame: Change from pre-study (day 0) to day 56 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

INCLUSION CRITERIA - Patient must meet the following during the screening and baseline visits:

  1. The patients or their legally acceptable representative must give signed informed consent for participation in the study before any study procedure is performed.
  2. Patients must be 18 years of age or older at pre-study
  3. Patients must be ambulatory, ECOG performance status of 0 or 1 (Appendix II)
  4. Patients have histologically confirmed diagnosis of Stage IV melanoma according to AJCC/UICC modified system with an expected survival time of more than 3 months
  5. Patients must be positive for HLA-A2 (Patients tested positive within 5 years of pre-study screening do not need to be tested again for HLA-A2)
  6. Patients must agree to use an acceptable method of birth control

    1. intrauterine device
    2. oral hormonal contraception
    3. combination of spermicide and barrier method or
    4. abstinence
  7. Female patients of childbearing potential must have a confirmed negative urine pregnancy test on Day 0

EXCLUSION CRITERIA - Patients meeting any of the following criteria will NOT be eligible for the study:

  1. Patients who have hematological abnormalities as evidenced by:

    1. Neutrophils < 1,500/mm3
    2. Leukocytes < 3,000/mm3
    3. Platelets < 75,000/mm3
    4. Hemoglobin < 9.0 g/dL
  2. Patients who have hepatic disease as evidenced by:

    1. SGOT/SGPT (AST/ALT) > 2.5 x the upper limit of normal (ULN)
    2. alkaline phosphatase > 2.5 x ULN
    3. Bilirubin > 1.5 x ULN\
    4. positive for hepatitis B surface antigen
    5. positive for hepatitis C antibody
  3. Patients who have known or suspected renal impairment as evidenced by:

    1. serum creatinine > 1.5 x ULN, and/or
    2. serum urea > 2.6 x ULN
  4. Patients with a history of ocular melanoma
  5. Patients with brain metastases, unless completed resected
  6. Patients with a positive HIV antibody test
  7. Patients with medical, sociological, or psychological impediments that may compromise compliance with the protocol
  8. Patients who are nursing, pregnant or planning to become pregnant within 6 months of treatment completion
  9. Patients who are receiving chemo-, radio- or immunotherapy concurrently or within the preceding four weeks
  10. Patients who are taking drugs that affect immune function such as systemic corticosteroids or immunomodulatory drugs concurrently or within the preceding four weeks
  11. Patients who are receiving any investigational drug concurrently or within the preceding four weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00023647

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90033-0804
Sponsors and Collaborators
Mannkind Corporation
Study Chair: Barbara Hickingbottom, JD, MD Mannkind Corporation

Publications of Results:
Responsible Party: Mannkind Corporation Identifier: NCT00023647     History of Changes
Other Study ID Numbers: CDR0000068847
First Posted: February 16, 2004    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by Mannkind Corporation:
stage IV melanoma
recurrent melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Immunologic Factors
Physiological Effects of Drugs