Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

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: NCT01543464
Recruitment Status : Terminated (Diminished rectruitment)
First Posted : March 5, 2012
Last Update Posted : March 19, 2018
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malignant Melanoma Drug: Chemotherapy: Temozolomide Phase 2

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  (Clinical Trial)
Actual Enrollment : 41 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination of IDO/Survivin Peptide Vaccine, GM-CSF, Imiquimod and Temozolomide Chemotherapy for Patients With Metastatic Malignant Melanoma
Study Start Date : May 2012
Primary Completion Date : September 2016
Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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).

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

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.

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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): NCT01543464

Trine Zeeberg Iversen
Brønshøj, Copenhagen, Denmark, 2700
Sponsors and Collaborators
Inge Marie Svane
Copenhagen University Hospital at Herlev
Principal Investigator: Trine Zeeberg Iversen, MD Center for Cancer ImmuneTherapy
Study Director: Inge Marie Svane, MD, PhD, Prof. Center for Cancer ImmunoTherapy

Responsible Party: Inge Marie Svane, MD, PhD & Professor, Herlev Hospital Identifier: NCT01543464     History of Changes
Other Study ID Numbers: MM1120
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018

Keywords provided by Inge Marie Svane, Herlev Hospital:
Indeolamine 2,3 dioxygenase

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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Adjuvants, Immunologic
Interferon Inducers