Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients
This study is currently recruiting participants.
Verified March 2013 by Herlev Hospital
Sponsor:
Inge Marie Svane
Collaborators:
Center for Cancer ImmuneTherapy, Department of Hematology & Oncology
Copenhagen University Hospital at Herlev
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01543464
First received: February 8, 2012
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Malignant Melanoma |
Drug: Chemotherapy: Temozolomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Herlev Hospital:
Primary Outcome Measures:
- Clinical benefit rate (CBR) [ Time Frame: 18 months ] [ Designated as safety issue: No ]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).
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histological verified malignant melanoma
- Metastatic disease (brain metastasis allowed if asymptomatic)
- Evaluable disease recording to RECIST v. 1.1
- Age > 18 years
- Performance status, PS=0, PS=1 or PS=2
- Life expectancy > 3 months
- Adequate bone marrow function
- Leucocyte count > 2,5 * 109/L
- Granulocyte count > 1,5 * 109/L
- Thrombocyte count > 100 * 109/l
- Creatinine < 2,5 * UNL 130 micromol/L
- Adequate liver function
- ASAT < 100 U/L
- Bilirubin < 300 U/L
- S-hCG negative (fertile women)
- Written informed consent
- Inclusion at least 4 weeks after major abdominal surgery
- If radiotherapy for brain metastases prior to inclusion, then progressive disease proven by new brain MR-scan before inclusion
Exclusion Criteria:
- Treatment with immune suppressors (ie. prednisone) not allowed
- Other malignancies 3 years prior to inclusion except benign skin lesions
- Severe medical condition, severe asthma, severe COL, severe heart- or diabetic disease
- Acute/Chronic infection with HIV, hepatitis or tuberculosis
- Known severe allergic reactions
- Former anaphylactic reactions
- Active autoimmune diseases
- Pregnant or nourishing women
- Psychiatric disease resulting in non-compliance
- Known allergic reactions towards Montanide, Imiquimod, Temozolomide or Leukine
- Simultaneously treatment with other experimental drugs
Patients cannot be treated with chemotherapy, radiotherapy (except locally) or immunotherapy 14 days within inclusion.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543464
Contacts
| Contact: Trine Zeeberg Iversen, MD | 38 68 91 83 ext + 45 | trine.zeeberg.iversen@regionh.dk |
| Contact: Inge Marie Svane, MD, PhD | 38 68 2131 ext + 45 | inge.marie.svane@regionh.dk |
Locations
| Denmark | |
| Trine Zeeberg Iversen | Recruiting |
| Brønshøj, Copenhagen, Denmark, 2700 | |
| Contact: Inge Marie Svane, MD, PhD 38 68 21 31 ext + 45 imsv@regionh.dk | |
Sponsors and Collaborators
Inge Marie Svane
Center for Cancer ImmuneTherapy, Department of Hematology & Oncology
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 |
More Information
No publications provided
| Responsible Party: | Inge Marie Svane, MD, PhD & Professor, Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT01543464 History of Changes |
| Other Study ID Numbers: | MM1120 |
| Study First Received: | February 8, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | Denmark: Danish Medicines Agency |
Keywords provided by Herlev Hospital:
|
Indeolamine 2,3 dioxygenase Survivin Montanide Imiquimod GMCSF |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Imiquimod Temozolomide Dacarbazine |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Interferon Inducers Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013