Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

March 16, 2018 updated by: Inge Marie Svane

Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma

The aim of the study is to assess if treatment with IDO/Survivin peptide vaccine can enhance the efficacy of temozolomide chemotherapy in patients with metastatic malignant melanoma.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Secondarily to studying the efficacy of the treatment; the investigators examine if treatment with IDO/Survivin peptide can induce a measurable cellular T-cell response when the vaccine is given in combination with temozolomide treatment for melanoma patients.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Brønshøj, Copenhagen, Denmark, 2700
        • Trine Zeeberg Iversen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histological verified malignant melanoma
  2. Metastatic disease (brain metastasis allowed if asymptomatic)
  3. Evaluable disease recording to RECIST v. 1.1
  4. Age > 18 years
  5. Performance status, PS=0, PS=1 or PS=2
  6. Life expectancy > 3 months
  7. Adequate bone marrow function
  8. Leucocyte count > 2,5 * 109/L
  9. Granulocyte count > 1,5 * 109/L
  10. Thrombocyte count > 100 * 109/l
  11. Creatinine < 2,5 * UNL 130 micromol/L
  12. Adequate liver function
  13. ASAT < 100 U/L
  14. Bilirubin < 300 U/L
  15. S-hCG negative (fertile women)
  16. Written informed consent
  17. Inclusion at least 4 weeks after major abdominal surgery
  18. If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion

Exclusion Criteria:

  1. Treatment with immune suppressors (ie. prednisone) not allowed
  2. Other malignancies 3 years prior to inclusion except benign skin lesions
  3. Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
  4. Acute/Chronic infection with HIV, hepatitis or tuberculosis
  5. Known severe allergic reactions
  6. Former anaphylactic reactions
  7. Active autoimmune diseases
  8. Pregnant or nourishing women
  9. Psychiatric disease resulting in non-compliance
  10. Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
  11. Simultaneously treatment with other experimental drugs

Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vaccine+adjuvants+temozolomide treatment
Experimental arm
Drug: Chemotherapy: Temozolomide
Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefit rate (CBR)
Time Frame: 18 months
Primary endpoint is clinical benefit rate defined as complete remission rate + partial response + stable disease for a minimum of 6 months plus assessment of time to progression (TTP).
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inge Marie Svane

Collaborators

Copenhagen University Hospital at Herlev

Investigators

  • Principal Investigator: Trine Zeeberg Iversen, MD, Center for Cancer ImmuneTherapy
  • Study Director: Inge Marie Svane, MD, PhD, Prof., Center for Cancer ImmunoTherapy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MM1120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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