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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00039000




Registration number
NCT00039000
Ethics application status
Date submitted
6/06/2002
Date registered
10/06/2002
Date last updated
7/09/2012

Titles & IDs
Public title
Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
Scientific title
A Phase III Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus Physician's Choice Including Interleukin-2 and/or Dacarbazine/Temozolomide-based Therapy and/or Complete Tumor Resection in Stage IV Melanoma
Secondary ID [1] 0 0
C-100-21
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Eligibility Assessment:

(The following assessments must be obtained within three weeks prior to randomization into the study)

* Medical history and physical examination (including EGOG score, evidence of immunosuppression);
* CT/MRI of the chest, abdomen and pelvis;
* Clinical examination;
* CT/MRI of the brain;
* Complete Blood Count with differential including platelets;
* Electrolytes (Na, Cl, K, HCO3, Ca, Mg, PO4);
* Renal function tests (BUN and creatinine);
* Liver function tests (bilirubin, AST, ALT);
* Serum pregnancy test for all women of childbearing potential.



* Stage IV Melanoma (AJCC);
* No prior therapy for stage IV melanoma;
* No prior therapy with interleukin-2 and/or dacarbazine/temozolomide within the past 12 months prior to study entry;
* Candidate for surgical resection of some/all sites of melanoma and expected to obtain greater tan or equal to 7 grams of viable cancer tissue (in aggregate), which is equivalent to a greater than or equal to 2 cm lesion on CT/MRI or clinical examination;
* No brain metastases;
* ECOG score 0 or 1;
* Adequate cardiac function;
* Adequate hematopoietic, liver and renal function;
* Female subjects of child-bearing potential must agree to use contraception during the study
* Signed written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mucosal or ocular melanomas;
* Other malignancies treated within the last five years, except in situ cervix carcinoma or non-melanoma skin cancer;
* Primary or secondary immunodeficiency, in the opinion of the investigator (including immunosuppressive disease, or use of systemic corticosteroids or other immunosuppressive medications);
* Prior splenectomy;
* Uncontrolled infection or other serious medical illnesses;
* Women who are pregnant or breast-feeding;
* Subjects participating in any other studies requiring administration of an investigational drug/biologic agent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Melbourne
Recruitment hospital [4] 0 0
- Newcastle
Recruitment hospital [5] 0 0
- Wentworthville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Camperdown
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- Newcastle
Recruitment postcode(s) [5] 0 0
- Wentworthville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New Hampshire
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New Jersey
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Tennessee
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Texas
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Wisconsin
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Pecs
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Hungary
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Szeged
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Italy
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Aviano
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Italy
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Genova
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Italy
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Milan
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Italy
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Rimini
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Poland
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Bialystock
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Poland
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Bydgoszcz
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Poland
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Krakow
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Russian Federation
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Arkhangelsk
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Novosibirsk
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Russian Federation
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Ryazan
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Russian Federation
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Stavropol
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Russian Federation
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Voronezh
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Sweden
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Gothenburg
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Sweden
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Lund
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Sweden
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Vaxjo
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Ukraine
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Dnepropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Ivano-Frankovsk
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Ukraine
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Kiev
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Ukraine
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Krivoy Rog
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Ukraine
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Lviv
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Ukraine
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Odessa
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Ukraine
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Uzhgorod
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Ukraine
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Vinnitsa
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Agenus Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00039000