NCT00023647

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2000

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2002

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

September 13, 2001

Last Update Submit

July 9, 2012

Conditions

Melanoma (Skin)

Keywords

stage IV melanomarecurrent melanoma

Outcome Measures

Primary Outcomes (1)

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

    Individual 96-hour infusion periods on days 0, 14, 28 and 42 and on day 56

Secondary Outcomes (3)

  • Change in magnitude of antigen-specific cytotoxic t-lymphocyte in peripheral blood mononuclear cells

    Day 0 (pre-study), last day of individual 96-hour infusion periods (days 4, 17, 31 and 45) and on day 56

  • Assessment of delayed-type hypersensitivity to intradermal injections 24 hours after injection

    Days 1, 29 and 57

  • Change in size of target lesions by x-ray computed tomography before (day 0) and after (day 56)treatment

    Change from pre-study (day 0) to day 56

Study Arms (3)

Synchrotope TA2M, 800 micrograms

EXPERIMENTAL

Tyrosinase peptides, 800 micrograms

Biological: Synchrotope TA2M

Synchrotope TA2M, 200 micrograms

EXPERIMENTAL

Tyrosinase peptides, 200 micrograms

Biological: Synchrotope TA2M

Synchrotope TA2M, 400 micrograms

EXPERIMENTAL

Tyrosinase peptides, 400 micrograms

Biological: Synchrotope TA2M

Interventions

Synchrotope TA2MBIOLOGICAL

Cancer Vaccine, Immunotherapy

Synchrotope TA2M, 800 micrograms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90033-0804, United States

Location

Related Publications (1)

  • 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.

    PMID: 12833467RESULT

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Barbara Hickingbottom, JD, MD

    Mannkind Corporation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2001

First Posted

February 16, 2004

Study Start

July 1, 2000

Primary Completion

April 1, 2002

Study Completion

November 1, 2002

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

US(1)