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Melanoma (Skin)Phase 1NCT00023647

Vaccine Therapy in Treating Patients With Stage IV Melanoma

A Phase 1 study testing Synchrotope TA2M in people with Melanoma (Skin), run by Mannkind Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
Synchrotope TA2M
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
Jul 2000to Nov 2002
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  7. intrauterine device
  8. oral hormonal contraception
  9. combination of spermicide and barrier method or
  10. abstinence
  11. 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:
  2. Neutrophils < 1,500/mm3
  3. Leukocytes < 3,000/mm3
  4. Platelets < 75,000/mm3
  5. Hemoglobin < 9.0 g/dL
  6. Patients who have hepatic disease as evidenced by:
  7. SGOT/SGPT (AST/ALT) > 2.5 x the upper limit of normal (ULN)
  8. alkaline phosphatase > 2.5 x ULN
  9. Bilirubin > 1.5 x ULN\
  10. positive for hepatitis B surface antigen
  11. positive for hepatitis C antibody
  12. Patients who have known or suspected renal impairment as evidenced by:
  13. serum creatinine > 1.5 x ULN, and/or
  14. serum urea > 2.6 x ULN
  15. Patients with a history of ocular melanoma
  16. Patients with brain metastases, unless completed resected
  17. Patients with a positive HIV antibody test
  18. Patients with medical, sociological, or psychological impediments that may compromise compliance with the protocol
  19. Patients who are nursing, pregnant or planning to become pregnant within 6 months of treatment completion
  20. Patients who are receiving chemo-, radio- or immunotherapy concurrently or within the preceding four weeks
  21. Patients who are taking drugs that affect immune function such as systemic corticosteroids or immunomodulatory drugs concurrently or within the preceding four weeks
  22. Patients who are receiving any investigational drug concurrently or within the preceding four weeks

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

Other trials in United States

About this study

Official title: A Phase I Dose-Ranging Safety Study Using Intranodal Delivery of a Plasmid DNA (Synchrotope TA2M) in Adult Stage IV Melanoma Patients

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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
Synchrotope TA2M
Keywords
stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Synchrotope TA2MBiological

    Cancer Vaccine, Immunotherapy

  • Synchrotope TA2MBiological

    Cancer Vaccine, Immunotherapy

  • Synchrotope TA2MBiological

    Cancer Vaccine, Immunotherapy

Study groups in NCT00023647
Study groupRoleWhat they receive
Synchrotope TA2M, 800 microgramsExperimentalTyrosinase peptides, 800 micrograms
Receives: Biological: Synchrotope TA2M
Synchrotope TA2M, 200 microgramsExperimentalTyrosinase peptides, 200 micrograms
Receives: Biological: Synchrotope TA2M
Synchrotope TA2M, 400 microgramsExperimentalTyrosinase peptides, 400 micrograms
Receives: Biological: Synchrotope TA2M

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (3)

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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2004 (estimated)
  2. Study startJul 2000
  3. Primary completionApr 2002
  4. Study completionNov 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023647
Sponsor's protocol ID
CDR0000068847
Other IDs
CTL-207-216, CTL-BB-IND-9146, LAC-USC-10M001, NCI-V01-1666
Status last verified
Jul 2012
First submitted
13 Sep 2001
Last updated
10 Jul 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12833467

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Synchrotope TA2M in people with Melanoma (Skin), run by Mannkind Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00023647, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2012.

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