Peptide Vaccine and Temozolomide for Metastatic Melanoma Patients

NCT01543464 | Terminated Phase 2 DMC

• 1 other identifier: MM1120
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Melanoma

Keywords

Indeolamine 2,3 dioxygenase; Survivin; Montanide; Imiquimod; GMCSF

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate (CBR)

  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

Study Arms (1)

Vaccine+adjuvants+temozolomide treatment

EXPERIMENTAL

Experimental arm

Drug: Chemotherapy: Temozolomide

Interventions

Chemotherapy: Temozolomide DRUG

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

Vaccine+adjuvants+temozolomide treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Treatment with immune suppressors (ie. prednisone) not allowed
• 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

Sponsors & Collaborators

• Inge Marie Svane: lead
• Copenhagen University Hospital at Herlev: collaborator

Study Sites (1)

Trine Zeeberg Iversen

Brønshøj, Copenhagen, 2700, Denmark

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Trine Zeeberg Iversen, MD

  Center for Cancer ImmuneTherapy

  PRINCIPAL INVESTIGATOR

• Inge Marie Svane, MD, PhD, Prof.

  Center for Cancer ImmunoTherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD & Professor

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: March 5, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

DK (1)