Condition category
Cancer
Date applied
17/07/2008
Date assigned
16/01/2009
Last edited
16/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Dirk Jaeger

ORCID ID

Contact details

Medical Oncology
National Center for Tumor Diseases
Im Neuemheimer Feld 350
Heidelberg
69120
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NCT-2007-11-02-1002

Study information

Scientific title

Phase I trial of RAB38/NY-MEL-1(50-58) peptide combined with Montanide® ISA-51 in HLA-A*0201 patients with stage III/IV malignant melanoma

Acronym

RAB38

Study hypothesis

In contrast to other solid tumours, immunology plays a major role in malignant melanoma. RAB38/NY-MEL-1 is a tumour antigen, which is exclusively expressed in melanocytes. Furthermore, antibodies against this polypeptide have exclusively been identified in the sera of patients with malignant melanoma. Therefore, the RAB38/NY-MEL-1 protein is an interesting target for immunisation strategies in these patients. Patients can be included in this study after failure or intolerance of standard chemotherapy. For these patients, other salvage treatments are not yet established and no therapy has been proven to be superior to best supportive care alone. The RAB38/NY-MEL-1 polypeptide has not been used in vaccination protocols before. Other tumour antigens (e.g. NY-ESO 1) have been studied in similar studies, where single patients responded to the vaccination and achieved regression of the tumour manifestations. The tolerability of the vaccination protocols described before was good and severe toxic side effects did not occur in most studies. Within this study, 9 patients with advanced malignant melanoma will be vaccinated with the RAB38/NY-MEL-1(50-58) peptide mixed with Montanide® ISA-51 as an adjuvant.

Ethics approval

Local medical ethics committee (Ethikkommission der Medizinischen Fakultät Heidelberg) gave approval on the 27th March 2008 (ref: AFmo-278/2007)

Study design

Open-label, single arm, phase I study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malignant melanoma stage III/IV

Intervention

Patients will receive RAB38/NY-MEL-1 peptide 400 µg mixed with 0.5 mL of Montanide® ISA-51 by intradermal injections, every 3 weeks (weeks 1, 4, 7, 10, 13 and 16) for six doses. Patients without disease progression in the absence of dose-limiting toxicity will receive continued treatment starting 3 weeks after the last injection. Treatment courses will be continued until tumour progression. No dose adjustments during the study are planned.

Intervention type

Drug

Phase

Phase I

Drug names

RAB38/NY-MEL-1(50-58) peptide, Montanide® ISA-51

Primary outcome measures

1. Toxicities and adverse events (AE) defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
2. RAB38/NY-MEL-1 specific cellular and humoral immune responses (CD8 T cell responses, serum antibody responses)

Measured at baseline, week 1, 4, 7, 10, 13, 16 and 19.

Secondary outcome measures

Tumour response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST), measured at week 19.

Overall trial start date

01/07/2008

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed metastatic, measurable malignant melanoma stage III/IV who have declined, failed or completed standard therapy
2. Tumour expression of RAB38/NY-MEL-1 by reverse transcriptase-polymerase chain reaction (RT-PCR) analysis
3. HLA-A2 positive
4. Expected survival of at least six months
5. Karnofsky performance scale greater than or equal to 60%
6. Full recovery from surgery
7. Within the last 2 weeks prior to study day 1 the following laboratory parameters, which should be within the ranges specified:
7.1. Absolute neutrophil count (ANC) greater than or equal to 1000/mm^3
7.2. Platelets greater than or equal to 80.000/mm^3
7.3. Creatinine less than or equal to 1.5 mg/L
7.4. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin all less than 2.5 x upper limit of normal (ULN)
8. Age greater than or equal to 18 years
9. Able and willing to give valid written inform consent
10. Both genders will be included

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

9 patients

Participant exclusion criteria

1. Clinically significant heart disease (New York Heart Association [NYHA] class III or IV)
2. Other serious illnesses, e.g., serious infections requiring antibiotics or bleeding disorders
3. Patients with serious intercurrent illness, requiring hospitalisation
4. Patients taking immunosuppressive drugs such as systemic corticosteroids. Topical or inhalational steroids are permitted.
5. Known human immunodeficiency virus (HIV) positivity
6. Other active malignancy within 1 year prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ
7. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study
8. Lack of availability for immunological and clinical follow-up assessments
9. Participation in chemotherapy, radiation therapy, or any other clinical trial involving another investigational agent within 4 weeks prior to enrolment
10. Pregnancy or breastfeeding
11. Women of childbearing potential: refusal or inability to use effective means of contraception
12. History of severe allergic reactions to vaccines or unknown allergens

Recruitment start date

01/07/2008

Recruitment end date

30/06/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Medical Oncology
Heidelberg
69120
Germany

Sponsor information

Organisation

University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)

Sponsor details

c/o Mrs. Irmtraut Guerkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany

Sponsor type

Hospital/treatment centre

Website

http://www.klinikum.uni-heidelberg.de/

Funders

Funder type

Research organisation

Funder name

National Center for Tumor Diseases (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Ludwig Institute for Cancer Research (LICR) (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes