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Trial registered on ANZCTR


Registration number
ACTRN12607000510448
Ethics application status
Approved
Date submitted
27/09/2007
Date registered
5/10/2007
Date last updated
5/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Biomarker evaluation of short-term administration of chemotherapeutic or biologic agents in patients with unresectable Stage IV melanoma amenable to pre- and post-treatment biopsy.
Scientific title
Biomarker evaluation of short-term administration of chemotherapeutic or biologic agents in patients with unresectable Stage IV melanoma amenable to pre- and post-treatment biopsy.
Universal Trial Number (UTN)
Trial acronym
TEAM - SMN 0107
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 2405 0
Condition category
Condition code
Skin 2511 2511 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Biopsies of in transit lesions (x2 mandatory 1 pre treatment and the other 7 days post treatment) and up to 4 optional biopsies possible at 14, 21, 28 & 56 days post treatment
Bloods will be collected at the following intervals: Baseline = Full Blood Count (FBC), Electrolytes, Urea & Creatinine (EUC), Liver Function Tests (LFTs), Lactate Dehydrogenase (LDH), International Normalised Ratio (INR), Activated Partial Thromboplastin Time (APTT), serum storage, flow cytometry & Deoxyribonucleic acid (DNA) & Ribonucleic acid (RNA) extraction
Days 7, 14 & 21 = FBC, serum storage & flow cytometry
Days 28 & 56 = FBC, serum storage, flow cytometry & DNA/RNA extraction

Expected study duration 18 months
Intervention code [1] 2128 0
Other interventions
Intervention code [2] 2132 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3406 0
To determine if short-term administration drug therapy produces histological, immunological and molecular changes in melanoma indicative of potential anti-tumour activity. Where present, such changes may assist in the selection of agents for more extensive clinical testing alone and in combination with other drugs.
Timepoint [1] 3406 0
Biopsies of in transit lesions (x2 mandatory 1 pre treatment and the other 7 days post treatment) and up to 4 optional biopsies possible at 14, 21, 28 & 56 days post treatment
Bloods will be collected at the following intervals: Baseline = Full Blood Count (FBC), Electrolytes, Urea & Creatinine (EUC), Liver Function Tests (LFTs), Lactate Dehydrogenase (LDH), International Normalised Ratio (INR), Activated Partial Thromboplastin Time (APTT), serum storage, flow cytometry & Deoxyribonucleic acid (DNA) & Ribonucleic acid (RNA) extraction
Days 7, 14 & 21 = FBC, serum storage & flow cytometry
Days 28 & 56 = FBC, serum storage, flow cytometry & DNA/RNA extraction
Secondary outcome [1] 5664 0
To correlate these changes in tumour biopsies with effects on circulating immunological and haematological parameters.
Timepoint [1] 5664 0
Biopsies of in transit lesions (x2 mandatory 1 pre treatment and the other 7 days post treatment) and up to 4 optional biopsies possible at 14, 21, 28 & 56 days post treatment
Bloods will be collected at the following intervals: Baseline = Full Blood Count (FBC), Electrolytes, Urea & Creatinine (EUC), Liver Function Tests (LFTs), Lactate Dehydrogenase (LDH), International Normalised Ratio (INR), Activated Partial Thromboplastin Time (APTT), serum storage, flow cytometry & Deoxyribonucleic acid (DNA) & Ribonucleic acid (RNA) extraction
Days 7, 14 & 21 = FBC, serum storage & flow cytometry
Days 28 & 56 = FBC, serum storage, flow cytometry & DNA/RNA extraction
Secondary outcome [2] 5669 0
To correlate these changes in tumour biopsies with tumour response.
Timepoint [2] 5669 0
Biopsies of in transit lesions (x2 mandatory 1 pre treatment and the other 7 days post treatment) and up to 4 optional biopsies possible at 14, 21, 28 & 56 days post treatment
Bloods will be collected at the following intervals: Baseline = Full Blood Count (FBC), Electrolytes, Urea & Creatinine (EUC), Liver Function Tests (LFTs), Lactate Dehydrogenase (LDH), International Normalised Ratio (INR), Activated Partial Thromboplastin Time (APTT), serum storage, flow cytometry & Deoxyribonucleic acid (DNA) & Ribonucleic acid (RNA) extraction
Days 7, 14 & 21 = FBC, serum storage & flow cytometry
Days 28 & 56 = FBC, serum storage, flow cytometry & DNA/RNA extraction
Secondary outcome [3] 5670 0
Where possible, to correlate these changes with biological effects on normal naevus cells from the same patient
Timepoint [3] 5670 0
Biopsies of in transit lesions (x2 mandatory 1 pre treatment and the other 7 days post treatment) and up to 4 optional biopsies possible at 14, 21, 28 & 56 days post treatment
Bloods will be collected at the following intervals: Baseline = Full Blood Count (FBC), Electrolytes, Urea & Creatinine (EUC), Liver Function Tests (LFTs), Lactate Dehydrogenase (LDH), International Normalised Ratio (INR), Activated Partial Thromboplastin Time (APTT), serum storage, flow cytometry & Deoxyribonucleic acid (DNA) & Ribonucleic acid (RNA) extraction
Days 7, 14 & 21 = FBC, serum storage & flow cytometry
Days 28 & 56 = FBC, serum storage, flow cytometry & DNA/RNA extraction

Eligibility
Key inclusion criteria
Life expectancy of at least 2 months; Eastern Cooperative Oncology Group (ECOG) performance status score 0-3; Histologic or cytologic diagnosis of unresectable Stage IV malignant melanoma; Required values for initial laboratory tests: White Blood Count (WBC) = 3000 x 103/mL; Absolute Neutrophil Count (ANC) = 1500 x 103/mL; Platelets = 90 x 106/mL; Haemoglobin = 9 g/dL; Aspartate aminotransferase (AST) = 3 x Upper Limit of normal (ULN) for patients without liver metastasis; = 5 x Upper Limit of normal (ULN) for patients with liver metastasis; Bilirubin = 2 x Upper Limit of normal (ULN), (except patients with Gilbert’s Syndrome, who must have a total bilirubin less than 3.0 mg/mL);
Creatinine = 1.5 x Upper Limit of normal (ULN); At least 4 weeks post chemotherapy (at least 6 weeks for nitrosoureas, mitomycin C and liposomal doxorubicin), immunotherapy, hormonal therapy, or major surgery and the beginning of protocol therapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Metastatic ocular melanoma; Symptomatic, untreated central nervous system (CNS) metastasis; Use of any immunosuppressing treatments including corticosteroids (patients on stable doses of hormone replacement therapy are exempt), cyclosporine, mycophenolate mofetil, chemotherapy, radiation, etc, within 4 weeks prior to Day 1 of treatment; Any other malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or Stage I carcinoma of the prostate; Concomitant therapy with any of the following: IL-2, interferon or other non-study anti-melanoma immunotherapy regimens; cytotoxic chemotherapy; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (patients on stable doses of hormone replacement therapy are exempt).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not randomised no sequence required
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 272 0
2060
Recruitment postcode(s) [2] 273 0
2050
Recruitment postcode(s) [3] 274 0
2145

Funding & Sponsors
Funding source category [1] 2655 0
Government body
Name [1] 2655 0
NHMRC Grant
Country [1] 2655 0
Australia
Funding source category [2] 2662 0
Government body
Name [2] 2662 0
Cancer Institute NSW Fellowships x2
Country [2] 2662 0
Australia
Primary sponsor type
Hospital
Name
Sydney South West Area Health Service RPA Hospital
Address
Royal Prince Alfred Hospital
Missenden Rd Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 2408 0
Hospital
Name [1] 2408 0
Sydney Westmead Area Health Service Westmead Hospital
Address [1] 2408 0
Westmead Hospital
Hawkesbury Rd Westmead NSW 2145
Country [1] 2408 0
Australia
Other collaborator category [1] 61 0
Other
Name [1] 61 0
Sydney Melanoma Unit
Address [1] 61 0
1A Eden St
North Sydney
NSW 2060
Country [1] 61 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4575 0
SSWAHS Ethics Committee
Ethics committee address [1] 4575 0
Ethics committee country [1] 4575 0
Australia
Date submitted for ethics approval [1] 4575 0
01/02/2007
Approval date [1] 4575 0
31/07/2007
Ethics approval number [1] 4575 0
X07-0049
Ethics committee name [2] 4576 0
Sydney West Area Health Service
Ethics committee address [2] 4576 0
Ethics committee country [2] 4576 0
Australia
Date submitted for ethics approval [2] 4576 0
27/06/2007
Approval date [2] 4576 0
04/09/2007
Ethics approval number [2] 4576 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28076 0
Address 28076 0
Country 28076 0
Phone 28076 0
Fax 28076 0
Email 28076 0
Contact person for public queries
Name 11233 0
Melanie Lean
Address 11233 0
1A Eden St
North Sydney
NSW 2060
Country 11233 0
Australia
Phone 11233 0
9911 7200
Fax 11233 0
9954 9435
Email 11233 0
[email protected]
Contact person for scientific queries
Name 2161 0
Professor Rick Kefford
Address 2161 0
Westmead Milennium Institute
Westmead NSW 2145
Country 2161 0
Australia
Phone 2161 0
9845 8089
Fax 2161 0
Email 2161 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.