Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Other LUD2002-013 CTN Trial No.: 2007/123, CTN-Protocol# LUD2002-013AMEND, NCT00518206

Trial Description

Summary

The purpose of this clinical trial cohort tests the effect of adding low dose cyclophosphamide to treatment with NY-ESO-1 ISCOM® vaccine, in patients with measurable advanced malignant melanoma (unresectable stage III or metastatic melanoma).

Further Study Information

This clinical trial cohort tests the combination of NY-ESO-1 ISCOMATRIX® vaccine given after low dose cyclophosphamide in patients with advanced melanoma.

NY-ESO-1 protein is an immune target found in many cancers including melanoma. ISCOMATRIX® adjuvant enhances immune responses. Low dose cyclophosphamide has been shown to suppress a population of lymphocytes called "regulatory T cells". Regulatory T cells can interfere with immune responses in patients with cancer. The rationale for treating this new cohort of patients in the study is to use a small dose of cyclophosphamide to suppress the regulatory T cells and thus try to increase patient responses to the NY-ESO-1 ISCOMATRIX® vaccine.

Eligible patients will receive three intramuscular injections of NY-ESO-1 ISCOM® vaccine at approximately four-week intervals (week 1, week 5, week 9). Low dose cyclophosphamide will be administered by intravenous infusion one day prior to the each NY-ESO-1 ISCOM® vaccine.

Tumor evaluations (CT scans and physical evaluations), safety evaluation (blood tests and medical reviews) and immunological testing (special DTH skin tests and blood immunology tests) will be performed before, during and at the end of the 11 week treatment cycle. Treatment may continue for further cycles unless there is a reason to remove the patient from study.

Eligibility Criteria

Inclusion Criteria:

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

• Tumor expression of NY-ESO-1 antigen by immunohistochemistry.

• Measurable disease (RECIST criteria).

• No other effective therapy available or appropriate.

• Expected survival of at least 4 months.

• Performance status (Karnofsky) 70% or greater.

• Vital laboratory parameters within normal range, or protocol specified ranges.

• Age 18 years or older.

• Able to give written informed consent.

Exclusion Criteria:

• Other serious or significant illnesses.

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

• Known immunodeficiency

• Known HIV positivity

• Using systemic immunosuppressive drugs. (Exceptions: Specific COX-2 inhibitors; low dose aspirin for acute cardiovascular event prevention; topical/inhaled steroids)

• Chemotherapy, immunotherapy or radiotherapy within last four weeks.

• Participation in prior clinical trial involving an investigational agent within last 4 weeks.

• Not available for immunological and clinical follow-up assessments.

• Pregnancy or breastfeeding.

• Refusal or inability to use effective means of contraception for women of childbearing potential.

• Mental impairment that may compromise ability to give informed consent and to comply with study requirements.

Trial Contact Information

Trial Lead Organizations/Sponsors

Ludwig Institute for Cancer Research

Prof. Jonathan S Cebon, FRACP, MBBS, PhD

Principal Investigator

A/Prof Ian D Davis, FRACP, FAChPM, MBBS, PhD

Principal Investigator

Dr. Oliver Klein, MD

Ph: +61 (0)3 9496 3990

Australia
Victoria
	East Melbourne
	Peter MacCallum Cancer Centre
		A/Prof, Grant McArthur, MBBS, PhD	Ph: +61 (0)3 9656 1195
		A/Prof. Grant McArthur, FRACP, MBBS, PhD	Principal Investigator
	Heidelberg (Melbourne)
	Austin Health
		Dr. Oliver Klein, MD	Ph: +61 (0)3 9496 3990
		Prof. Jonathan S Cebon, FRACP, MBBS, PhD	Principal Investigator
		A/Prof. Ian D Davis, FRACP, FAChPM, MBBS, PhD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00518206
Information obtained from ClinicalTrials.gov on August 11, 2008