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Health Condition(s) or Problem
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Malignant Melanoma
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Lay Summary
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IMCgp100 is a new biological therapy designed for the treatment of melanoma skin cancer. The
drug is designed to target melanoma cells and stimulate immune cells to kill them. This
trial is designed to establish the level of drug that can be given to a patient that is
tolerable. It also designed to look for signals that the drug is working as intended.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
1. Pathologically documented Stage IV malignant melanoma or unresectable Stage III
melanoma for which no standard effective therapy exists.
2. Previous surgery (other than resection of skin metastases), radiotherapy,
chemotherapy, immunotherapy or experimental therapy completed >4 weeks before and all
adverse events resolved to = grade 1. In cases where localised radiotherapy has been
applied, treatment with IMCgp100 can be commenced after a two week period.
3. HLA A2 positive.
4. = 18 years old.
5. Eastern Cooperative Oncology Group (ECOG) performance status =1
6. For patients in the Dose-Expansion part only, measurable disease according to RECIST
criteria. For patients in the Dose-escalation part of the study, only 'assessable
disease' is required.
7. Life expectancy >3 months.
8. Blood tests within the following parameters:
1. Platelet count =100 x 109/L
2. Haemoglobin =10g/dL
3. Calculated creatinine clearance =60 mL/min using the modified Cockcroft-Gault
equation
4. Both the lymphocyte and neutrophil counts =1x109/L.
9. Female patients of childbearing potential must use maximally effective birth control
during the period of therapy, must be willing to use contraception for 6 months
following the last study drug infusion and must have a negative urine or serum
pregnancy test upon entry into this study. Otherwise, female patients must be
postmenopausal (no menstrual period for a minimum of 12 months) or surgically
sterile.
10. Male patients must be surgically sterile or willing to use a double barrier
contraception method upon enrolment, during the course of the study, and for 6 months
following the last study drug infusion.
11. Able to give informed consent.
Exclusion Criteria:
1. High disease volume, i.e. three or more visceral sites involved (other than skin,
lymph nodes and lungs) and/or >25% involvement of liver parenchyma as estimated by
baseline CT Scan.
2. Brain metastases at any time
3. Active malignancy in the past 5 years except carcinoma in situ or completely excised
non-melanomatous skin cancer or any other malignancy that in the opinion of the
investigator is considered to be cured.
4. Comorbid medical condition that would increase the risk of toxicity in the opinion of
the investigator or sponsor. Symptomatic ongoing infection must be resolved before
the patient can be treated in the study.
5. Uveitis
6. Had myocardial infarction within 1 year before enrolment, symptomatic congestive
heart failure (New York Heart Association >Class II), unstable angina or unstable
cardiac arrhythmia requiring medication.
7. Has an ejection fraction <50%.
8. Clinically significant electrocardiogram (ECG) changes that obscure the ability to
assess the RR, PR and QT intervals.
9. Has hepatic function as follows:
1. Aspartate aminotransferase >2.5 x upper limit of normal (ULN)
2. Alanine aminotransferase >2.5 x ULN
3. Alkaline phosphatase>2.0 x ULN
4. Bilirubin >2.0 x ULN
5. Prothrombin time or partial thromboplastin time>1.5 x ULN
10. Bleeding diathesis or receiving therapeutic anti-coagulation treatment.
11. Immunosuppressive condition or treatment including previous transplantation,
splenectomy or known HIV infection.
12. Has a history of adult seizures.
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Who cannot enter the trial
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Inclusion Criteria:
1. Pathologically documented Stage IV malignant melanoma or unresectable Stage III
melanoma for which no standard effective therapy exists.
2. Previous surgery (other than resection of skin metastases), radiotherapy,
chemotherapy, immunotherapy or experimental therapy completed >4 weeks before and all
adverse events resolved to = grade 1. In cases where localised radiotherapy has been
applied, treatment with IMCgp100 can be commenced after a two week period.
3. HLA A2 positive.
4. = 18 years old.
5. Eastern Cooperative Oncology Group (ECOG) performance status =1
6. For patients in the Dose-Expansion part only, measurable disease according to RECIST
criteria. For patients in the Dose-escalation part of the study, only 'assessable
disease' is required.
7. Life expectancy >3 months.
8. Blood tests within the following parameters:
1. Platelet count =100 x 109/L
2. Haemoglobin =10g/dL
3. Calculated creatinine clearance =60 mL/min using the modified Cockcroft-Gault
equation
4. Both the lymphocyte and neutrophil counts =1x109/L.
9. Female patients of childbearing potential must use maximally effective birth control
during the period of therapy, must be willing to use contraception for 6 months
following the last study drug infusion and must have a negative urine or serum
pregnancy test upon entry into this study. Otherwise, female patients must be
postmenopausal (no menstrual period for a minimum of 12 months) or surgically
sterile.
10. Male patients must be surgically sterile or willing to use a double barrier
contraception method upon enrolment, during the course of the study, and for 6 months
following the last study drug infusion.
11. Able to give informed consent.
Exclusion Criteria:
1. High disease volume, i.e. three or more visceral sites involved (other than skin,
lymph nodes and lungs) and/or >25% involvement of liver parenchyma as estimated by
baseline CT Scan.
2. Brain metastases at any time
3. Active malignancy in the past 5 years except carcinoma in situ or completely excised
non-melanomatous skin cancer or any other malignancy that in the opinion of the
investigator is considered to be cured.
4. Comorbid medical condition that would increase the risk of toxicity in the opinion of
the investigator or sponsor. Symptomatic ongoing infection must be resolved before
the patient can be treated in the study.
5. Uveitis
6. Had myocardial infarction within 1 year before enrolment, symptomatic congestive
heart failure (New York Heart Association >Class II), unstable angina or unstable
cardiac arrhythmia requiring medication.
7. Has an ejection fraction <50%.
8. Clinically significant electrocardiogram (ECG) changes that obscure the ability to
assess the RR, PR and QT intervals.
9. Has hepatic function as follows:
1. Aspartate aminotransferase >2.5 x upper limit of normal (ULN)
2. Alanine aminotransferase >2.5 x ULN
3. Alkaline phosphatase>2.0 x ULN
4. Bilirubin >2.0 x ULN
5. Prothrombin time or partial thromboplastin time>1.5 x ULN
10. Bleeding diathesis or receiving therapeutic anti-coagulation treatment.
11. Immunosuppressive condition or treatment including previous transplantation,
splenectomy or known HIV infection.
12. Has a history of adult seizures.
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What will happen
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Drug; IMCgp100; Ascending doses from 0.000005 to 0.003645mg/kg to be given by intravenous infusion over 4 hours. Repeat treatment is weekly doses over a 6 week cycle.; IMCgp100; ImmTACgp100
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Primary aim
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Definition of the maximum tolerated dose and evaluation of the safety and tolerability of multiple injections of IMCgp100
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Secondary Aim
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Characterisation of the pharmacokinetics and changes in tumour volume following IMCgp100 administration; 28 months; Yes; The secondary outcome measures for this trial are the characterisation of the pharmacokinetics of IMCgp100 following single and repeat administration, evaluation of the incidence of anti-drug antibodies and the assessment of tumour volume following IMCgp100 infusion.
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Nation
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England, Scotland
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Location
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Birmingham, Cambridge, Glasgow, Leeds, Oxford
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