Study of NY-ESO-1 ISCOMATRIX® in Patients With Measurable Stage III or IV Melanoma

• Status: Completed
• Trial end date: 2010-01-22
• Target enrollment: 0
• Participant gender: All

Summary

This was a Phase 2, open-label study of the NY-ESO-1 ISCOMATRIX® (ISCOM) vaccine administered as an intramuscular injection given every 4 weeks to subjects with measurable advanced malignant melanoma. Study objectives included determination of the anticancer activity, cellular and humoral immunogenicity, and safety and tolerability of the NY-ESO-1 ISCOM vaccine administered alone or preceded by a single administration of low-dose cyclophosphamide.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ludwig Institute for Cancer Research
• Collaborators: Austin Health; Peter MacCallum Cancer Institute
• Treatments: Cyclophosphamide; Vaccines

Criteria

Inclusion Criteria:

1. Stage IV (metastatic) or unresectable stage III malignant melanoma.

2. Measurable disease using RECIST.

3. No other effective therapy available or appropriate.

4. Expression of NY-ESO-1 or LAGE-1 by immunohistochemistry (IHC) or reverse transcription-polymerase chain reaction (RT-PCR).

5. Expected survival of at least 4 months.

6. Karnofsky performance status of ≥ 70%.

7. Within 3 weeks prior to first administration of study drug, the following laboratory parameters were required to be within the ranges specified:

• Hemoglobin ≥ 100 g/L

• Platelets ≥ 100 x 10^9/L

• International normalized ratio ≤ 2.0

• Creatinine ≤ 0.2 mmol/L

• Bilirubin ≤ 30 mmol/L

8. Age ≥ 18 years.

9. Able and willing to give written informed consent.

Exclusion Criteria:

1. Other serious illnesses, eg, serious infections requiring antibiotics, bleeding disorders, or any condition that in the opinion of the Investigator would have interfered with the ability of the patient to complete all study requirements.

2. Other malignancy within last 3 years, except for treated melanoma or non-melanoma skin cancer or cervical cancer in situ.

3. Known immunodeficiency.

4. Known human immunodeficiency virus positivity.

5. Concomitant systemic treatment with corticosteroids, anti-histaminic drugs, or nonsteroidal anti-inflammatory drugs. Specific cyclooxygenase-2 (COX-2) inhibitors, low-dose aspirin for the prevention of an acute cardiovascular event, and topical or inhaled steroids were permitted.

6. Chemotherapy and/or radiotherapy within 4 weeks prior to study week 1.

7. Other immunotherapy within 4 weeks prior to study week 1.

8. Mental impairment that may have compromised the ability to give informed consent and comply with the requirements of the study.

9. Lack of availability for immunological and clinical follow-up assessment.

10. Participation in any other clinical trial involving another investigational agent within 4 weeks prior to enrollment.

11. Pregnancy or breastfeeding.

12. Women of childbearing potential: refusal or inability to use effective means of contraception.