Clinical trial of an anti-tumoural vaccination for patients suffering from stage III/IV malignant melanoma
| ISRCTN | ISRCTN21224989 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21224989 |
| Secondary identifying numbers | NCT-2007-11-02-1002 |
- Submission date
- 17/07/2008
- Registration date
- 16/01/2009
- Last edited
- 16/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dirk Jaeger
Scientific
Scientific
Medical Oncology
National Center for Tumor Diseases
Im Neuemheimer Feld 350
Heidelberg
69120
Germany
Study information
| Study design | Open-label, single arm, phase I study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | RAB38 |
| Study objectives | 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(s) | Local medical ethics committee (Ethikkommission der Medizinischen Fakultät Heidelberg) gave approval on the 27th March 2008 (ref: AFmo-278/2007) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | RAB38/NY-MEL-1(50-58) peptide, Montanide® ISA-51 |
| Primary outcome measure | 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 study start date | 01/07/2008 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 9 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2008 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Medical Oncology
Heidelberg
69120
Germany
69120
Germany
Sponsor information
University Hospital Heidelberg (Universitätsklinikum Heidelberg) (Germany)
Hospital/treatment centre
Hospital/treatment centre
c/o Mrs. Irmtraut Guerkan
Im Neuenheimer Feld 672
Heidelberg
69120
Germany
| Website | http://www.klinikum.uni-heidelberg.de/ |
|---|---|
"ROR" |
https://ror.org/013czdx64 |
Funders
Funder type
Research organisation
National Center for Tumor Diseases (Germany)
No information available
Ludwig Institute for Cancer Research (LICR) (USA)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
