Clinical trial · Interventional

REO13 Melanoma With of Without GM-CSF

A Clinical Study to Evaluate the Biological Effects of Intravenous Wild-type Reovirus (Reolysin®), With of Without GM-CSF, in Advanced Melanoma

NCT03282188CI-TRIAL-00032790withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Withdrawn by Sponsor

Summary

Brief summary (as posted)

Open-label, non-randomised, single centre study which will assess the presence of reovirus (Reolysin®), following intravenous administration with or without Granulocyte-macrophage colony-stimulating factor (GM-CSF) given to patients prior to surgery for metastatic melanoma. All patients will receive an initial low 'immunisation' dose of intravenous reovirus. Patients will be enrolled sequentially in to each of the two cohorts receiving either reovirus alone, or reovirus plus GM-CSF. For this study we anticipate 8-16 evaluable patients, up to 8 for each group. The endpoints of this study will compare the 2 treatment groups for reovirus tumour infiltration and replication. Compare the neutralising antibody development and cell-mediated immune response and identify any adverse events and laboratory toxicities.

Conditions

Conditions (2)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Cancer of Skin	Malignant Skin Neoplasm	ALIAS	0.90
Melanoma	Melanoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
GM-CSF	Drug	—	UNRESOLVED
Reolysin	Biological	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
GROUP A (Reovirus only)
description
Group A patients will receive an initial low 'immunisation' dose of intravenous reovirus (1x108 TCID50), to ensure that neutralising antibody (NAB) levels have risen by the time a full cycle of reovirus is given. Group A patients will then receive only 1 cycle of treatment which will comprise of reovirus only at 1x1010 TCID50 as a 1-hour IV infusion on 2 consecutive days.
interventionNames
1. Biological: Reolysin
type
EXPERIMENTAL
label
GROUP B (Reovirus plus GM-CSF)
description
Group B patients will receive an initial low 'immunisation' dose of intravenous reovirus (1x108 TCID50), to ensure that neutralising antibody (NAB) levels have risen by the time a full cycle of reovirus plus GM-CSF is given. Group B patients will be given a subcutaneous injection of GM-CSF (50mcg/day) for 3 days, followed by only 1 cycle of treatment which will comprise of reovirus at 1x1010 TCID50 as a 1-hour IV infusion on 2 consecutive days
interventionNames
1. Biological: Reolysin

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Be male or female subjects with histologically diagnosed melanoma.
2. Be at least 18 years of age.
3. Be appropriate for resection of advanced melanoma (Stage 3/4). Patients may or may not have more widespread metastatic disease.
4. Have completed any previous systemic chemotherapy, radiotherapy or surgery (except biopsies) at least 28 days before entry into the study.
5. Have NO continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedures, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) Grade ≤1.
6. Have an ECOG Performance Score of 0 or 1.
7. Have a life expectancy of at least 3 months.
8. Have baseline laboratory results at the time of consent as follows:

1. Absolute neutrophil count (ANC) ≥ 1.5 x 109 \[SI units 109/L\]
2. Platelets ≥ 100 x109 \[SI units 109/L\] (without platelet transfusion)
3. Haemoglobin ≥ 9.0 g/dL \[SI units gm/L\] (with or without RBC transfusion)
4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)
5. Bilirubin ≤ 1.5 x ULN
6. AST/ALT ≤ 2.5 x ULN
7. Negative serum pregnancy test for females of childbearing potential.
9. Have signed informed consent.
10. Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests

Exclusion Criteria:

1. Be on concurrent therapy with any other investigational anticancer agent while on study.
2. Be on immunosuppressive therapy other than steroids.
3. Have known HIV infection or hepatitis B or C.
4. Be pregnant or breast feeding. Female patients must agree to use effective contraception, be surgically sterile, or be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile.
5. Have clinically significant cardiac disease (New York Heart Association, Class III or IV) including clinically significant arrhythmia, uncontrolled angina pectoris, or myocardial infarction within 1 year prior to study entry.
6. Have dementia or altered mental status that would prohibit informed consent.
7. Have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Principal

References

Publications (0)

Data not yet available

No reference posted for this study.