MelanomaPhase 2NCT00204581
Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases
A Phase 2 study testing Interleukin-2 (Proleukin) in people with Melanoma, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Interleukin-2 (Proleukin)
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2003to Dec 2009
- Phase
- Phase 2
- 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
- Age 18+
- Informed consent
- Histologically proven melanoma
- Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases
Who cannot join
- Pregnant or lactating women
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
- Patients with severe liver disease or severe renal disease
- Simultaneous immunosuppressive treatment (e.g. steroids)
- Simultaneous chemotherapy
- Pretreated soft-tissue or skin metastases (e.g. cryo-, radiotherapy)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Skin Cancer Program, Department of Dermatology, Liebermeisterstrasse 8
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial
The intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.
However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.
- Conditions
- Melanoma
- Being tested
- Interleukin-2 (Proleukin)
- Keywords
- Melanoma, Soft tissue metastases, Interleukin-2
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-2 (Proleukin)Drug
Also called Proleukin
6-12 MIE/d 3times a week
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy in regard to complete and partial response
Measured: 4 weeks
Secondary outcomes (2)
Overall survival
Measured: every 6 months
Side-effects
Measured: during treament and 4 weeks afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionJan 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Claus Garbe, MD, Principal investigator, Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204581
- Sponsor's protocol ID
- IL-2-LOK-MM
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 19 Aug 2011
- Results posted
- No
Publications
Radny P, Caroli UM, Bauer J, Paul T, Schlegel C, Eigentler TK, Weide B, Schwarz M, Garbe C. Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases. Br J Cancer. 2003 Nov 3;89(9):1620-6. doi: 10.1038/sj.bjc.6601320.
PubMed 14583759
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Treatment With Interleukin-2 (Proleukin) in Soft Tissue Melanoma Metastases. A Phase II, Prospective, Open, Multicenter Trial
- ClinicalTrials.gov ID
- NCT00204581
- Acronym / sponsor ID
- IL-2-LOK-MM
- Conditions
- Melanoma
- Keywords
- Melanoma, Soft tissue metastases, Interleukin-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 2005 (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 intra-/perilesional application of interleukin-2 seems to be a safe and effective treatment of skin and soft tissue metastases in malignant melanoma. Especially in case of intransit metastases the overall survival rate is still 20-30%.
However, the management of intransit metastases is sometimes difficult because of frequent recurrences. IL-2 intralesionally seems to be an non-invasive option as pilot studies indicate. In this study the safety and efficacy of IL-2 are evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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 (4 listed)
- Age 18+
- Informed consent
- Histologically proven melanoma
- Have confirmed stage IIIB or stage IV disease (AJCC 2002) with skin or soft-tissue metastases
Key exclusion criteria (6 listed)
- Pregnant or lactating women
- Patients with severe cardiac disease (e.g. NYHA Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina)
- Patients with severe liver disease or severe renal disease
- Simultaneous immunosuppressive treatment (e.g. steroids)
- Simultaneous chemotherapy
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 |
|---|---|---|
| Interleukin-2 (Proleukin)Also: Proleukin6-12 MIE/d 3times a week | Drug | – |
Primary outcome
Efficacy in regard to complete and partial response
Time frame: 4 weeks
2 secondary outcomes
Overall survival
Time frame: every 6 months
Side-effects
Time frame: during treament and 4 weeks afterwards
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 19 Aug 2011.
- Background: PubMed 14583759Radny P, Caroli UM, Bauer J, Paul T, Schlegel C, Eigentler TK, Weide B, Schwarz M, Garbe C. Phase II trial of intralesional therapy with interleukin-2 in soft-tissue melanoma metastases. Br J Cancer. 2003 Nov 3;89(9):1620-6. doi: 10.1038/sj.bjc.6601320.
- Link to published abstractLink provided by the sponsor.
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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.
Claus Garbe, MD principal investigator
Skin Cancer Program, Department of Dermatology, University Hospital Tübingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interleukin-2 (Proleukin) in people with Melanoma, run by University Hospital Tuebingen at 1 site in Germany.
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 4 inclusion and 6 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 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Efficacy in regard to complete and partial response (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00204581, which also lists 1 linked publication.
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 19 Aug 2011.