MelanomaPhase 1NCT00791271
Parallel Phase I/II Trial of Decitabine and Peg-Interferon in Melanoma: Phase I Portion
A Phase 1 study testing Decitabine and Pegylated Interferon Alpha-2b in people with Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Decitabine and Pegylated Interferon Alpha-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2008to May 2015
- 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
- Patients must have pathologically confirmed malignant melanoma that is unresectable stage III or stage IV.
- Patients must have measurable disease as defined by RECIST criteria.
- No more than two prior chemotherapy for unresectable stage III or IV melanoma.
- Patients must be >/= 28 days beyond the last administration of anticancer therapy, and must have recovered from the toxicities of prior therapy. If the patient was recently treated with a nitrosurea, they must be >/= 42 days beyond the last administration.
- Patients must have no other active malignancies. Patients with prior history of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible, if their disease has been inactive for 2 years prior to the time of study entry.
- Patients must be >/= 18 years of age.
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- Patients must give written informed consent prior to initiation of therapy in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of this study and the risks associated with the therapy.
- Women of childbearing potential (WOCBP) must not be pregnant (negative urine human chorionic gonadotropin (HCG) within 2 weeks of treatment) or lactating. A WOCBP is defined as a woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months.
- Women of childbearing potential and sexually active males must be counseled to use an accepted and effective method of contraception (including abstinence) while on treatment and for a period of 3 months after completing or discontinuing treatment.
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Patients must have adequate organ and marrow function, measured within 14 days of study entry, as defined below: All Patients: - Absolute neutrophil count >/=1,500/uL - Platelets >/=100,000/uL - Creatinine (serum) </= 2.0 mg/dL - Total bilirubin </= 1.5 mg/dL - AST(SGOT)/ALT(SGPT) </= 2.5 X Institutional Upper Limit of Normal (IULN)
- Patients with any number of prior targeted or cytokine therapies, but no more than two chemotherapy containing regimens.
Who cannot join
- Patients with active autoimmune disorders or who are receiving immunosuppressive therapy (including steroids or methotrexate) for any indication are excluded. An exception may be made, by the PI, to include patients with adrenal insufficiency requiring physiologic steroid hormone replacement only.
- Patients who have previously received adjuvant high dose interferon.
- Patients may not receive any other investigational agents within four weeks of study entry. Patients may not receive any other investigational agents while on study.
- Patients who have had major surgery within 2 weeks prior to entering the study, or have otherwise not adequately recovered from prior surgery.
- Patients who have had palliative radiation therapy within 2 weeks prior to entering the study.
- Patients with brain metastases.
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- Patients with a history of active ischemic heart disease or cerebro-vascular disease, congestive heart failure (NYHA class >2) or anginal syndrome requiring ongoing medical treatment.
- Patients with myocardial ischemia (MI), stroke, or transient ischemic attack (TIA) within the last 6 months.
- Patients with a diagnosis or evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the protocol.
- Patients with a history of central nervous system (CNS) demyelinating, inflammatory disease or hereditary or acquired peripheral neuropathy.
- Patients with known history of HIV and hepatitis infection or any other significant medical or surgical condition or psychiatric disorder that may interfere with the completion of this trial or with the evaluation of safety and efficacy of the study combination.
- Patients with thyroid dysfunction not responsive to therapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Peginterferon Alfa-2b in Advanced Melanoma
The goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied.
The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are more effective and/or better tolerated.
Read the detailed description
The Study Drugs:
Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.
Peginterferon alfa-2b is designed to strengthen the immune system, which may decrease tumor growth.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 6 groups of 3-6 participants will be enrolled in the Phase I portion of the study, and up to 44 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of decitabine and peginterferon alfa-2b you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drug combination. Each new group will receive a higher dose level than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
If you are enrolled in the Phase II portion, the dose of decitabine and peginterferon alfa-2b you receive will depend on when you joined this study, as well as the research data from the Phase I portion. You will be randomly assigned (as in the roll of dice) to receive one of the dose levels (which may be from 1 to 6 dose levels, depending on the available data from the Phase I portion) that have been found in the Phase I portion to have the least side effects and to be possibly the most effective. This means you will have an equal chance of being assigned to any of the dose levels that are being used at that time. As the study goes on, if the research data suggests that one dose level may be better tolerated than the others, new participants enrolling into the Phase II portion would be more likely to be assigned to that possibly better dose level.
No matter which phase you are enrolled in, your dose of the study drugs may be lowered if you do not tolerate the study drug combination well.
Study Drug Administration:
A "cycle" on this study is 28 days. Decitabine will be given by vein, over 1 hour, on Days 1-5 of each cycle. Peginterferon alfa-2b will be given by injection under the skin, once a week (on Days 1, 8, 15, and 21). You will be giving peginterferon alfa-2b to yourself under nursing supervision on the days you are receiving decitabine.
On Day 6 of each cycle, you will either receive Neulasta (pegfilgrastim) or Neupogen (filgrastim). Pegfilgrastim or filgrastim will be injected under your skin. If you receive pegfilgrastim, it will be injected only on Day 6 of each cycle. If you receive filgrastim, it will be injected 1 time a day for as many days as the doctor decides is needed to raise your white blood cell count.
Study Visits:
On Day 1 of each cycle, the following procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any medications or treatments you may be currently receiving and any side effects you may have experienced.
- You will have a performance status evaluation.
- Blood (about 1 teaspoon) will be drawn for routine tests.
These same tests listed above will be repeated at additional visits with the research nurse during Week 3 of Cycles 1 and 2. If you do not experience severe side effects during Cycles 1 and 2, these extra Week 3 visits with the research nurse will no longer be necessary in later cycles. They may, however, be started again if needed.
At the end of of Cycle 3, and every odd cycle after that (Cycles 5, 7, 9, and so on), you will have a scan performed (such as CT or MRI) to check the status of the disease.
Length of Study Participation:
You may remain on study for as long as you are benefitting. If the disease gets worse or intolerable side effects occur, you will be taken off study early.
End-of-Study Visit:
Once you go off study for any reason, you will have an end-of-study visit with the same procedures performed as the Day 1 study visits. You may also have a scan performed (such as CT or MRI) to check the status of the disease if you have not had one performed in the last 4 weeks.
Long-Term Follow-Up:
Every 3 months for about 2 years, researchers will call you to see how you are doing.
This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Peginterferon alfa-2b is FDA approved and commercially available for the treatment of hepatitis C. Their use together in this study in the treatment of melanoma is considered experimental. At this time, the combination is being used in research only.
Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Melanoma
- Being tested
- Decitabine, Pegylated Interferon Alpha-2b
- Keywords
- Melanoma, Malignant melanoma, Unresectable, Decitabine, PEG Interferon Alpha-2b, PEG Intron, 5-Aza-Deoxycytidine, Dacogen
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecitabineDrug
Also called 5-Aza-Deoxycytidine, Dacogen
Starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle.
Pegylated Interferon Alpha-2bDrug
Also called PEG Interferon Alpha-2b, PEG Intron
Starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Decitabine + Peginterferon Alfa-2b | Experimental | Decitabine starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle. Peginterferon Alfa-2b starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle. Receives: Drug: Decitabine; Drug: Pegylated Interferon Alpha-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Dose-limiting toxicity (DLT)
Dose limiting toxicity defined as any treatment related toxicity that meets one or more of the following criteria:
Any grade 3 or 4 non-hematologic toxicity regardless of duration, except:
- Grade 3 nausea or vomiting occurring without maximal antiemetic therapy.
- Grade 3 diarrhea that occurs following without adequate loperamide therapy.
- Grade 4 thrombocytopenia.
- Grade 4 neutropenia lasting > 2 weeks or associated with infection.
- Any toxicity that results in a treatment delay of > 4weeks.
Measured: 4 weeks
Secondary outcomes (1)
Phase II: Patient Response
Success defined as either a complete response (CR), a partial response (PR), or stable disease (SD). Target combined endpoint of CR+PR+SD in this trial is 30%. Evaluation of response follows the Response Evaluation Criteria in Solid Tumors (RECIST) Guidelines.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study start2 Sep 2008
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Schering-Plough, Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Wen-Jen Hwu, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791271
- Sponsor's protocol ID
- 2007-0450
- Other IDs
- NCI-2010-01030
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2008
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel Phase I/II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Peginterferon Alfa-2b in Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00791271
- Acronym / sponsor ID
- 2007-0450
- Conditions
- Melanoma
- Keywords
- Melanoma, Malignant melanoma, Unresectable, Decitabine, PEG Interferon Alpha-2b, PEG Intron, 5-Aza-Deoxycytidine, Dacogen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Schering-Plough, Eisai Inc.
- Study start
- 2 Sep 2008 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 14 Nov 2008 (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 goal of the first phase of this clinical research study is to find the highest tolerable dose of decitabine and peginterferon alfa-2b that can be given in combination to patients with melanoma. The safety of this drug combination will also be studied.
The goals of the second phase are to learn if decitabine and peginterferon alfa-2b combined can help to control melanoma, and to find out which doses are more effective and/or better tolerated.
Detailed description
The Study Drugs:
Decitabine is designed to damage the DNA of cells, which may cause cancer cells to die.
Peginterferon alfa-2b is designed to strengthen the immune system, which may decrease tumor growth.
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 6 groups of 3-6 participants will be enrolled in the Phase I portion of the study, and up to 44 participants will be enrolled in Phase II.
If you are enrolled in the Phase I portion, the dose of decitabine and peginterferon alfa-2b you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drug combination. Each new group will receive a higher dose level than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug combination is found.
If you are enrolled in the Phase II portion, the dose of decitabine and peginterferon alfa-2b you receive will depend on when you joined this study, as well as the research data from the Phase I portion. You will be randomly assigned (as in the roll of dice) to receive one of the dose levels (which may be from 1 to 6 dose levels, depending on the available data from the Phase I portion) that have been found in the Phase I portion to have the least side effects and to be possibly the most effective. This means you will have an equal chance of being assigned to any of the dose levels that are being used at that time. As the study goes on, if the research data suggests that one dose level may be better tolerated than the others, new participants enrolling into the Phase II portion would be more likely to be assigned to that possibly better dose level.
No matter which phase you are enrolled in, your dose of the study drugs may be lowered if you do not tolerate the study drug combination well.
Study Drug Administration:
A "cycle" on this study is 28 days. Decitabine will be given by vein, over 1 hour, on Days 1-5 of each cycle. Peginterferon alfa-2b will be given by injection under the skin, once a week (on Days 1, 8, 15, and 21). You will be giving peginterferon alfa-2b to yourself under nursing supervision on the days you are receiving decitabine.
On Day 6 of each cycle, you will either receive Neulasta (pegfilgrastim) or Neupogen (filgrastim). Pegfilgrastim or filgrastim will be injected under your skin. If you receive pegfilgrastim, it will be injected only on Day 6 of each cycle. If you receive filgrastim, it will be injected 1 time a day for as many days as the doctor decides is needed to raise your white blood cell count.
Study Visits:
On Day 1 of each cycle, the following procedures will be performed:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any medications or treatments you may be currently receiving and any side effects you may have experienced.
- You will have a performance status evaluation.
- Blood (about 1 teaspoon) will be drawn for routine tests.
These same tests listed above will be repeated at additional visits with the research nurse during Week 3 of Cycles 1 and 2. If you do not experience severe side effects during Cycles 1 and 2, these extra Week 3 visits with the research nurse will no longer be necessary in later cycles. They may, however, be started again if needed.
At the end of of Cycle 3, and every odd cycle after that (Cycles 5, 7, 9, and so on), you will have a scan performed (such as CT or MRI) to check the status of the disease.
Length of Study Participation:
You may remain on study for as long as you are benefitting. If the disease gets worse or intolerable side effects occur, you will be taken off study early.
End-of-Study Visit:
Once you go off study for any reason, you will have an end-of-study visit with the same procedures performed as the Day 1 study visits. You may also have a scan performed (such as CT or MRI) to check the status of the disease if you have not had one performed in the last 4 weeks.
Long-Term Follow-Up:
Every 3 months for about 2 years, researchers will call you to see how you are doing.
This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Peginterferon alfa-2b is FDA approved and commercially available for the treatment of hepatitis C. Their use together in this study in the treatment of melanoma is considered experimental. At this time, the combination is being used in research only.
Up to 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decitabine + Peginterferon Alfa-2b | Experimental | Drug: Decitabine, Drug: Pegylated Interferon Alpha-2bDecitabine starting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle. Peginterferon Alfa-2b starting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must have pathologically confirmed malignant melanoma that is unresectable stage III or stage IV.
- Patients must have measurable disease as defined by RECIST criteria.
- No more than two prior chemotherapy for unresectable stage III or IV melanoma.
- Patients must be >/= 28 days beyond the last administration of anticancer therapy, and must have recovered from the toxicities of prior therapy. If the patient was recently treated with a nitrosurea, they must be >/= 42 days beyond the last administration.
- Patients must have no other active malignancies. Patients with prior history of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous cell skin cancer are eligible. Patients with other malignancies are eligible, if their disease has been inactive for 2 years prior to the time of study entry.
Key exclusion criteria (12 listed)
- Patients with active autoimmune disorders or who are receiving immunosuppressive therapy (including steroids or methotrexate) for any indication are excluded. An exception may be made, by the PI, to include patients with adrenal insufficiency requiring physiologic steroid hormone replacement only.
- Patients who have previously received adjuvant high dose interferon.
- Patients may not receive any other investigational agents within four weeks of study entry. Patients may not receive any other investigational agents while on study.
- Patients who have had major surgery within 2 weeks prior to entering the study, or have otherwise not adequately recovered from prior surgery.
- Patients who have had palliative radiation therapy within 2 weeks prior to entering the study.
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 |
|---|---|---|
| DecitabineAlso: 5-Aza-Deoxycytidine, DacogenStarting dose of 10mg/m^2 given daily via intravenous infusion on days 1-5 of 28 day cycle. | Drug | Decitabine + Peginterferon Alfa-2b |
| Pegylated Interferon Alpha-2bAlso: PEG Interferon Alpha-2b, PEG IntronStarting dose of 3 µg/kg injection under the skin once a week on days 1, 8, 15, and 21 of 28 day cycle. | Drug | Decitabine + Peginterferon Alfa-2b |
Primary outcome
Phase I: Dose-limiting toxicity (DLT)
Time frame: 4 weeks
Dose limiting toxicity defined as any treatment related toxicity that meets one or more of the following criteria: Any grade 3 or 4 non-hematologic toxicity regardless of duration, except: 1. Grade 3 nausea or vomiting occurring without maximal antiemetic therapy. 2. Grade 3 diarrhea that occurs following without adequate loperamide therapy. * Grade 4 thrombocytopenia. * Grade 4 neutropenia lasting > 2 weeks or associated with infection. * Any toxicity that results in a treatment delay of > 4weeks.
1 secondary outcome
Phase II: Patient Response
Time frame: 12 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink 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.
Wen-Jen Hwu, MD, PhD principal investigator
M.D. Anderson 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 1 study testing Decitabine and Pegylated Interferon Alpha-2b in people with Melanoma, run by M.D. Anderson 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?
The sponsor lists 12 inclusion and 12 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: stopped early, as of the sponsor's last update on 9 Nov 2018. 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 was stopped early. Results are not available in the source record.
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?
Phase I: Dose-limiting toxicity (DLT) (time frame: 4 weeks). 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 9 Nov 2018.