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Vaccine Therapy in Treating Patients With Stage IV Melanoma

Primary Purpose

Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Synchrotope TA2M
Synchrotope TA2M
Synchrotope TA2M
Sponsored by
Mannkind Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA - Patient must meet the following during the screening and baseline visits: The patients or their legally acceptable representative must give signed informed consent for participation in the study before any study procedure is performed. Patients must be 18 years of age or older at pre-study Patients must be ambulatory, ECOG performance status of 0 or 1 (Appendix II) 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 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) Patients must agree to use an acceptable method of birth control intrauterine device oral hormonal contraception combination of spermicide and barrier method or abstinence 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: Patients who have hematological abnormalities as evidenced by: Neutrophils < 1,500/mm3 Leukocytes < 3,000/mm3 Platelets < 75,000/mm3 Hemoglobin < 9.0 g/dL Patients who have hepatic disease as evidenced by: SGOT/SGPT (AST/ALT) > 2.5 x the upper limit of normal (ULN) alkaline phosphatase > 2.5 x ULN Bilirubin > 1.5 x ULN\ positive for hepatitis B surface antigen positive for hepatitis C antibody Patients who have known or suspected renal impairment as evidenced by: serum creatinine > 1.5 x ULN, and/or serum urea > 2.6 x ULN Patients with a history of ocular melanoma Patients with brain metastases, unless completed resected Patients with a positive HIV antibody test Patients with medical, sociological, or psychological impediments that may compromise compliance with the protocol Patients who are nursing, pregnant or planning to become pregnant within 6 months of treatment completion Patients who are receiving chemo-, radio- or immunotherapy concurrently or within the preceding four weeks Patients who are taking drugs that affect immune function such as systemic corticosteroids or immunomodulatory drugs concurrently or within the preceding four weeks Patients who are receiving any investigational drug concurrently or within the preceding four weeks

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Synchrotope TA2M, 800 micrograms

Synchrotope TA2M, 200 micrograms

Synchrotope TA2M, 400 micrograms

Arm Description

Tyrosinase peptides, 800 micrograms

Tyrosinase peptides, 200 micrograms

Tyrosinase peptides, 400 micrograms

Outcomes

Primary Outcome Measures

Frequency of adverse events assessed by complete blood count, blood chemistry, polymerase chain reaction, physical examination and urinalysis

Secondary Outcome Measures

Change in magnitude of antigen-specific cytotoxic t-lymphocyte in peripheral blood mononuclear cells
Assessment of delayed-type hypersensitivity to intradermal injections 24 hours after injection
Change in size of target lesions by x-ray computed tomography before (day 0) and after (day 56)treatment

Full Information

First Posted
September 13, 2001
Last Updated
July 9, 2012
Sponsor
Mannkind Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00023647
Brief Title
Vaccine Therapy in Treating Patients With Stage IV Melanoma
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
July 2000 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
November 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mannkind Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Synchrotope TA2M, 800 micrograms
Arm Type
Experimental
Arm Description
Tyrosinase peptides, 800 micrograms
Arm Title
Synchrotope TA2M, 200 micrograms
Arm Type
Experimental
Arm Description
Tyrosinase peptides, 200 micrograms
Arm Title
Synchrotope TA2M, 400 micrograms
Arm Type
Experimental
Arm Description
Tyrosinase peptides, 400 micrograms
Intervention Type
Biological
Intervention Name(s)
Synchrotope TA2M
Intervention Description
Cancer Vaccine, Immunotherapy
Intervention Type
Biological
Intervention Name(s)
Synchrotope TA2M
Intervention Description
Cancer Vaccine, Immunotherapy
Intervention Type
Biological
Intervention Name(s)
Synchrotope TA2M
Intervention Description
Cancer Vaccine, Immunotherapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Assessment of delayed-type hypersensitivity to intradermal injections 24 hours after injection
Time Frame
Days 1, 29 and 57
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA - Patient must meet the following during the screening and baseline visits: The patients or their legally acceptable representative must give signed informed consent for participation in the study before any study procedure is performed. Patients must be 18 years of age or older at pre-study Patients must be ambulatory, ECOG performance status of 0 or 1 (Appendix II) 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 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) Patients must agree to use an acceptable method of birth control intrauterine device oral hormonal contraception combination of spermicide and barrier method or abstinence 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: Patients who have hematological abnormalities as evidenced by: Neutrophils < 1,500/mm3 Leukocytes < 3,000/mm3 Platelets < 75,000/mm3 Hemoglobin < 9.0 g/dL Patients who have hepatic disease as evidenced by: SGOT/SGPT (AST/ALT) > 2.5 x the upper limit of normal (ULN) alkaline phosphatase > 2.5 x ULN Bilirubin > 1.5 x ULN\ positive for hepatitis B surface antigen positive for hepatitis C antibody Patients who have known or suspected renal impairment as evidenced by: serum creatinine > 1.5 x ULN, and/or serum urea > 2.6 x ULN Patients with a history of ocular melanoma Patients with brain metastases, unless completed resected Patients with a positive HIV antibody test Patients with medical, sociological, or psychological impediments that may compromise compliance with the protocol Patients who are nursing, pregnant or planning to become pregnant within 6 months of treatment completion Patients who are receiving chemo-, radio- or immunotherapy concurrently or within the preceding four weeks Patients who are taking drugs that affect immune function such as systemic corticosteroids or immunomodulatory drugs concurrently or within the preceding four weeks Patients who are receiving any investigational drug concurrently or within the preceding four weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Hickingbottom, JD, MD
Organizational Affiliation
Mannkind Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12833467
Citation
Tagawa ST, Lee P, Snively J, Boswell W, Ounpraseuth S, Lee S, Hickingbottom B, Smith J, Johnson D, Weber JS. Phase I study of intranodal delivery of a plasmid DNA vaccine for patients with Stage IV melanoma. Cancer. 2003 Jul 1;98(1):144-54. doi: 10.1002/cncr.11462.
Results Reference
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Vaccine Therapy in Treating Patients With Stage IV Melanoma

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