Malignant MelanomaPhase 3NCT00039000
Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma
A Phase 3 study testing HSPPC-96 or Oncophage in people with Malignant Melanoma, run by Agenus Inc. at 77 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- HSPPC-96 or Oncophage
- How many people
- 350 participants
- Where
- 77 sitesin 9 countries
- Study dates
- Mar 2002to Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
77 sites in 9 countries.
77 sites in 9 countries
United States35 sites
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Berkeley, California
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Columbia, Missouri
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Farmington, Connecticut
Study site
Houston, Texas
Study site
Jacksonville, Florida
Study site
Kansas City, Kansas
Study site
Knoxville, Tennessee
Study site
Lakeland, Florida
Study site
Lebanon, New Hampshire
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Miami Beach, Florida
Study site
New Brunswick, New Jersey
Study site
New York, New York
Study site
Park Ridge, Illinois
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Robbinsdale, Minnesota
Study site
Rochester, Minnesota
Study site
Scottsdale, Arizona
Study site
St Louis, Missouri
Study site
Stanford, California
Study site
Tulsa, Oklahoma
Study site
Vista, California
Russia11 sites
Study site
Arkhangelsk
Study site
Chelyabinsk
Study site
Kazan'
Study site
Krasnodar
Study site
Moscow
Study site
Novosibirsk
Study site
Ryazan
Study site
Saint Petersburg
Study site
Samara
Study site
Stavropol
Study site
Voronezh
Ukraine9 sites
Study site
Dnipro
Study site
Donetsk
Study site
Ivano-Frankivsk
Study site
Kiev
Study site
Kryvyi Rih
Study site
Lviv
Study site
Odesa
Study site
Uzhhorod
Study site
Vinnitsa
Australia5 sites
Study site
Adelaide
Study site
Camperdown
Study site
Melbourne
Study site
Newcastle
Study site
Wentworthville
Hungary4 sites
Study site
Budapest
Study site
Debrecen
Study site
Pécs
Study site
Szeged
Italy4 sites
Study site
Aviano
Study site
Genova
Study site
Milan
Study site
Rimini
United Kingdom3 sites
Study site
Leeds
Study site
London
Study site
Manchester
About this study
Official 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
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.
Read the detailed description
Primary Objective:
- To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection.
Secondary Objective:
- To determine frequency of adverse events in subjects randomized to HSPPC-96.
- Conditions
- Malignant Melanoma
- Being tested
- HSPPC-96 or Oncophage
- Keywords
- Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor
- Medical subject headings
- Melanoma, Neoplasms, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSPPC-96 or OncophageDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2002 (estimated)
- Study startMar 2002
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00039000
- Sponsor's protocol ID
- C-100-21
- Status last verified
- Sep 2012
- First submitted
- 6 Jun 2002
- Last updated
- 7 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00039000
- Acronym / sponsor ID
- C-100-21
- Conditions
- Malignant Melanoma
- Keywords
- Immunotherapy, Cancer, Melanoma, Skin Cancer, tumor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 10 Jun 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
- To determine whether subjects with stage IV melanoma randomized to HSPPC-96 have longer survival than subjects randomized to physician's choice including interleukin-2 and/or dacarbazine/temozolomide and/or complete tumor resection.
Secondary Objective:
- To determine frequency of adverse events in subjects randomized to HSPPC-96.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSPPC-96 or Oncophage | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
77 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HSPPC-96 or Oncophage in people with Malignant Melanoma, run by Agenus Inc. at 77 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Russia, Ukraine, Australia, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2012.