Malignant MelanomaPhase 1NCT00179608
Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy
A Phase 1 study testing CC-5013 in people with Malignant Melanoma, run by Celgene at 1 site in United States.
Trial summary
This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with systemic chemotherapy. 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?
- CC-5013
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2005to 1 Jun 2007
- Phase
- Phase 1
- 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
- Understand and voluntarily sign an informed consent document
- Age greater than or equal to 18 years at the time of signing Informed Consent
- Be able to adhere to the study visit schedule and other protocol requirements
- Histological documentation of malignant melanoma with evidence of metastatic disease
- For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II)
- ECOG performance status of 0, 1 or 2 (see Appendix I)
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- Laboratory tests within these ranges:
- Absolute neutrophil count greater than or equal to 1,500/uL
- Platelet count greater than or equal to 100,000/uL
- Serum creatinine less than or equal to 1.5 mg/dL
- Total bilirubin less that or equal to 1.5 mg.dL
- AST (SGOT) / ALT (SGPT) less than or equal to to 2 times upper limit of normal (ULN)
- Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.
- In addition, sexually active WCBP must agree to use at least two methods of adequate contraceptive (oral, injectable, or implantable hormonal contraceptive, tubal ligation, intra-uterine device, barrier contraceptive with spermicide, contraceptive skin patch or vasectomized partner) while on study drug
- All acute adverse effects (excluding alopecia of any prior therapy must have resolved to less than or equal to grade 1 (NCI CTCAE v3.0)
- Patients must be able to take medications orally
Who cannot join
- Pregnant or lactating females
- Any serious medical condition, including psychiatric illnesses that will prevent the patient from signing the informed consent or place the patient at an unacceptable risk if he/she participates in the study.
- Prior treatment with systemic chemotherapy. Patients who have received prior immunotherapy, including thalidomide, or radiotherapy remain eligible.
- Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site.
- Prior history of malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for at least 3 years.
- Use of thalidomide or biologic response modifier therapy within 14 days of Day 1, Cycle 1
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- Prior greater than or equal to grade 2 allergic reaction to thalidomide
- Prior desquamating rash while taking thalidomide
- Any prior use of lenalidomide
- Concurrent use of any other anti-cancer agents
- Radiation or surgical treatment of melanoma within 28 days of starting study treatment
- Active infection
- Central nervous system (CNS) metastases
- Patients with > grade-2 neuropathy
- Patients with known HIV positivity or AIDS-related illness
Trial locations and contacts
1 site in 1 country.
United States1 site
MD Anderson Cancer Center
Houston, Texas, 77030-4009
About this study
Official title: Phase I Safety Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy
This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with systemic chemotherapy. This study will evaluate the safety and preliminary efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide for 14 consecutive days and DTIC on day one of each 21 day cycle.
- Conditions
- Malignant Melanoma
- Being tested
- CC-5013
- Keywords
- CC-5013, CC5013, celgene, Melanoma, Revlimid, Metastatic Malignant Melanoma, Lenalidomide
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC-5013Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine MTD of intravenous DTIC during the first 2 cycles (6 wks) of treatment
Secondary outcomes (2)
To evaluate the safety profile of combination lenalidomide plus DTIC, the preliminary efficacy of combination lenalidomide plus DTIC
To define the recommended phase II doses of lenalidomide and DTIC when administered as combination therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start1 Sep 2005
- Primary completion1 Jun 2007
- Study completion1 Jun 2007
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 Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prologue Research International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179608
- Sponsor's protocol ID
- CC-5013-MEL-003
- Status last verified
- Nov 2019
- First submitted
- 13 Sep 2005
- Last updated
- 8 Nov 2019
- Results posted
- No
Publications
Hwu WJ, Knight RD, Patnana M, Bassett R, Papadopoulos NE, Kim KB, Hwu P, Bedikian A. Phase I safety study of lenalidomide and dacarbazine in patients with metastatic melanoma previously untreated with systemic chemotherapy. Melanoma Res. 2010 Dec;20(6):501-6. doi: 10.1097/CMR.0b013e32833faf18.
PubMed 20859231
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Safety Study of the Combination of Lenalidomide and DTIC (Dacarbazine) in Patients With Metastatic Malignant Melanoma Previously Untreated With Systemic Chemotherapy
- ClinicalTrials.gov ID
- NCT00179608
- Acronym / sponsor ID
- CC-5013-MEL-003
- Conditions
- Malignant Melanoma
- Keywords
- CC-5013, CC5013, celgene, Melanoma, Revlimid, Metastatic Malignant Melanoma, Lenalidomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Collaborators
- Prologue Research International
- Study start
- 1 Sep 2005 (actual)
- Primary completion
- 1 Jun 2007 (actual)
- Study completion
- 1 Jun 2007 (actual)
- First posted
- 16 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.
This study will determine the MDT of intravenous DTIC when administered in combination with a fixed dose of oral lenalidomide in subjects with metastatic malignant melanoma previously untreated with systemic chemotherapy. This study will evaluate the safety and preliminary efficacy of the combination of lenalidomide and DTIC. Subjects will be receive lenalidomide for 14 consecutive days and DTIC on day one of each 21 day cycle.
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 (16 listed)
- Understand and voluntarily sign an informed consent document
- Age greater than or equal to 18 years at the time of signing Informed Consent
- Be able to adhere to the study visit schedule and other protocol requirements
- Histological documentation of malignant melanoma with evidence of metastatic disease
- For the 10 patients enrolled at the MTD, at least one measurable lesion must be present (see Appendix II)
Key exclusion criteria (15 listed)
- Pregnant or lactating females
- Any serious medical condition, including psychiatric illnesses that will prevent the patient from signing the informed consent or place the patient at an unacceptable risk if he/she participates in the study.
- Prior treatment with systemic chemotherapy. Patients who have received prior immunotherapy, including thalidomide, or radiotherapy remain eligible.
- Lesions within a prior field of radiation may only be used as indicator lesions if there has been evidence of disease progression at that site.
- Prior history of malignancies (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the patient has been free of the disease for at least 3 years.
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 |
|---|---|---|
| CC-5013 | Drug | – |
Primary outcome
To determine MTD of intravenous DTIC during the first 2 cycles (6 wks) of treatment
2 secondary outcomes
To evaluate the safety profile of combination lenalidomide plus DTIC, the preliminary efficacy of combination lenalidomide plus DTIC
To define the recommended phase II doses of lenalidomide and DTIC when administered as combination therapy.
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 Nov 2019.
- Background: PubMed 20859231Hwu WJ, Knight RD, Patnana M, Bassett R, Papadopoulos NE, Kim KB, Hwu P, Bedikian A. Phase I safety study of lenalidomide and dacarbazine in patients with metastatic melanoma previously untreated with systemic chemotherapy. Melanoma Res. 2010 Dec;20(6):501-6. doi: 10.1097/CMR.0b013e32833faf18.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CC-5013 in people with Malignant Melanoma, run by Celgene 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?
The sponsor lists 16 inclusion and 15 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 8 Nov 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To determine MTD of intravenous DTIC during the first 2 cycles (6 wks) of treatment. 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 NCT00179608, 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 8 Nov 2019.