Intraocular MelanomaPhase 2NCT00238329
PEG-Interferon Alfa-2b and Thalidomide in Treating Patients With Recurrent or Metastatic Melanoma
A Phase 2 study testing PEG-interferon alfa-2b and thalidomide in people with Intraocular Melanoma and Melanoma (Skin), run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial summary
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Melanoma, Melanoma (Skin)
- What is being tested?
- PEG-interferon alfa-2b and thalidomide
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2001to Jun 2007
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed malignant melanoma, including any of the following:
- Cutaneous melanoma
- Ocular melanoma
- Mucosal melanoma
- Unidentified primary tumor
- Recurrent or metastatic disease
- Bidimensionally measurable or evaluable disease
- Brain metastases allowed provided disease is stable for ≥ 6 weeks after prior radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- SWOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2 times upper limit of normal (ULN)
- SGOT ≤ 2 times ULN
Renal
- Creatinine ≤ 2 mg/dL
Cardiovascular
- None of the following conditions within the past 3 months:
- Congestive heart failure
- Second- or third-degree heart block
- Myocardial infarction
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception (1 highly effective and 1 additional method) for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
- No other malignancy within the past 2 years except adequately treated skin cancer or carcinoma in situ of the cervix
- No concurrent blood, sperm, or ova donation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Prior biologic therapy (e.g., interferon) allowed
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 28 days since prior radiotherapy
Surgery
- At least 28 days since prior surgery
Other
- No more than 2 prior systemic treatment regimens for metastatic malignant melanoma
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
About this study
Official title: Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.
Read the detailed description
OBJECTIVES:
- Determine the response rate in patients with recurrent or metastatic malignant melanoma treated with PEG-interferon alfa-2b and thalidomide.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Being tested
- PEG-interferon alfa-2b, thalidomide
- Keywords
- recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma
- Medical subject headings
- Uveal Melanoma, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-interferon alfa-2bBiological
thalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate as measured scans and tumor measurements every 8 weeks
Qualitative and quantitative toxicities at 30 days following study treatment
Secondary outcomes (3)
Progression-free survival by standard life table and Kaplan-Meier
Overall survival by standard life table and Kaplan-Meier
Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2005 (estimated)
- Study startJan 2001
- Primary completionDec 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ulka N. Vaishampayan, MD, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00238329
- Sponsor's protocol ID
- CDR0000445593
- Other IDs
- P30CA022453, WSU-C-2257, WSU-HIC-120900M01-FB
- Status last verified
- Apr 2013
- First submitted
- 12 Oct 2005
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Pegylated Interferon and Thalidomide in Pretreated Metastatic Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00238329
- Acronym / sponsor ID
- CDR0000445593
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, recurrent intraocular melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2001
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jun 2007
- First posted
- 13 Oct 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.
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop tumor cells from growing. PEG-interferon alfa-2b and thalidomide may also stop the growth of melanoma by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with thalidomide may be an effective treatment for melanoma.
PURPOSE: This phase II trial is studying how well giving PEG-interferon alfa-2b together with thalidomide works in treating patients with recurrent or metastatic melanoma.
Detailed description
OBJECTIVES:
- Determine the response rate in patients with recurrent or metastatic malignant melanoma treated with PEG-interferon alfa-2b and thalidomide.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
- Determine progression-free and overall survival of patients treated with this regimen.
OUTLINE: Patients receive PEG-interferon alfa-2b subcutaneously once weekly and oral thalidomide once daily. Treatment continues for at least 2 weeks but no more than 8 months in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive PEG-interferon alfa-2b and thalidomide for 2 months beyond documentation of CR.
PROJECTED ACCRUAL: A total of 18-32 patients will be accrued for this study within 14-38 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| PEG-interferon alfa-2b | Biological | – |
| thalidomide | Drug | – |
Primary outcome
Response rate as measured scans and tumor measurements every 8 weeks
Qualitative and quantitative toxicities at 30 days following study treatment
3 secondary outcomes
Progression-free survival by standard life table and Kaplan-Meier
Overall survival by standard life table and Kaplan-Meier
Vascular flow to metastatic sites by positron-emission tomography scan every 8 weeks
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 8 Apr 2013.
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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.
Ulka N. Vaishampayan, MD principal investigator
Barbara Ann Karmanos Cancer Institute
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 PEG-interferon alfa-2b and thalidomide in people with Intraocular Melanoma and Melanoma (Skin), run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Apr 2013. 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 United States. 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?
Response rate as measured scans and tumor measurements every 8 weeks. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 8 Apr 2013.