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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
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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
The primary goal of this study is to determine if people with metastatic melanoma who receive Heat Shock Protein-Peptide Complex - 96 (HSPPC-96 or Oncophage) after surgery live longer than people who may or may not have surgery but who receive conventional chemotherapy including IL-2/DTIC. A second goal is to determine the safety and frequency of side effects in subjects who receive therapy with HSPPC-96.
Trial website
https://clinicaltrials.gov/study/NCT00039000
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00039000