Intraocular MelanomaPhase 2NCT00072345
Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma
A Phase 2 study testing lomustine, temozolomide and thalidomide in people with Intraocular Melanoma and Melanoma (Skin), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide with lomustine may kill more tumor cells. 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?
- lomustine, temozolomide and thalidomide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Aug 2004
- 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 metastatic malignant melanoma
- Unresectable stage III OR stage IV disease
- Ocular, mucosal, and cutaneous melanoma allowed
- Measurable disease
- Indicator lesions within a prior radiotherapy field must have recent evidence of disease progression
- Indicator lesions must be distinct from the surgical and/or radiation changes induced by prior local therapies
- No more than 2 symptomatic hemorrhagic lesions in the brain
- No hemorrhagic lesion(s) greater than 1 cm in diameter
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 80-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- SGOT and SGPT no greater than 2 times ULN
- Alkaline phosphatase no greater than 2 times ULN
- Lactic dehydrogenase no greater than 2 times ULN
Renal
- Creatinine no greater than 2 mg/dL
Cardiovascular
- No history of severe cardiovascular disease
- No myocardial infarction within the past 6 months
- No unstable angina
- No New York Heart Association class III or IV congestive heart failure
- No ventricular arrhythmia
- No uncontrolled arrhythmia
Gastrointestinal
- No frequent vomiting
- No other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 4 weeks after study participation
- HIV negative
- No AIDS-related illness
- No serious infection requiring IV antibiotics
- No other uncontrolled medical illness that would preclude study participation
- No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer meeting all of the following criteria:
- Detected incidentally at transurethral resection of the prostate (TURP)
- Comprises less than 5% of resected tissue
- Prostate-specific antigen normal since TURP
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 weeks since prior immunotherapy or biologic therapy
- No concurrent immunotherapy
Chemotherapy
- No prior systemic chemotherapy for melanoma
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- At least 3 weeks since prior focused radiotherapy for brain metastases
- At least 3 weeks since prior radiosurgery
- At least 4 weeks since prior whole brain radiotherapy
- At least 3 weeks since prior interstitial brachytherapy
- No concurrent radiotherapy
Surgery
- See Disease Characteristics
- At least 3 weeks since prior surgery for brain metastases
- At least 3 weeks since prior surgery requiring general anesthesia
Other
- Recovered from all prior therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide with lomustine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the antitumor activity of temozolomide, thalidomide, and lomustine, in terms of objective response rate, in patients with unresectable stage III or stage IV melanoma.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of response and overall survival of patients treated with this regimen.
OUTLINE: Patients receive oral temozolomide on days 1-42, oral thalidomide on days 1-56, and oral lomustine on days 1 and 29. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Being tested
- lomustine, temozolomide, thalidomide
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size, extraocular extension 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.
lomustineDrug
temozolomideDrug
thalidomideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2003 (estimated)
- Study startJul 2003
- Primary completionAug 2004
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Wen-Jen Hwu, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00072345
- Sponsor's protocol ID
- 03-084
- Other IDs
- P30CA008748, MSKCC-03084
- Status last verified
- Jan 2013
- First submitted
- 4 Nov 2003
- Last updated
- 18 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00072345
- Acronym / sponsor ID
- 03-084
- Conditions
- Intraocular Melanoma, Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma, iris melanoma, ciliary body and choroid melanoma, medium/large size, ciliary body and choroid melanoma, small size, extraocular extension melanoma, recurrent intraocular melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2003
- Primary completion
- Aug 2004 (actual)
- First posted
- 6 Nov 2003 (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: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide with lomustine may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the antitumor activity of temozolomide, thalidomide, and lomustine, in terms of objective response rate, in patients with unresectable stage III or stage IV melanoma.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the duration of response and overall survival of patients treated with this regimen.
OUTLINE: Patients receive oral temozolomide on days 1-42, oral thalidomide on days 1-56, and oral lomustine on days 1 and 29. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.
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 |
|---|---|---|
| lomustine | Drug | – |
| temozolomide | Drug | – |
| thalidomide | 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 18 Jan 2013.
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Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma
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Adjuvant Melatonin for Uveal Melanoma
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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.
Wen-Jen Hwu, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
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 lomustine, temozolomide and thalidomide in people with Intraocular Melanoma and Melanoma (Skin), run by Memorial Sloan Kettering Cancer Center 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 18 Jan 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.
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 18 Jan 2013.