Renal Cell CarcinomaPhase 2NCT00561912
Low Dose Decitabine + Interferon Alfa-2b in Advanced Renal Cell Carcinoma
A Phase 2 study testing Decitabine and Interferon Alfa-2b in people with Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objective: To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b. Secondary Objectives: To determine the toxicity of the combination of decitabine and interferon alfa-2b at the proposed dose and schedule in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Decitabine and Interferon Alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 histologically confirmed clear cell renal carcinoma that is metastatic or unresectable. In the absence of metastatic disease, patients who are deemed unresectable or inoperable will have a documented surgical opinion confirming this. Surgical opinion will be rendered either by surgical consultation or after presentation at our interdisciplinary conference. Patients with locally recurrent RCC are eligible, if surgical resection of local recurrence is not feasible or is refused by patient.
- Patients with locally advanced unresectable RCC should have measurable or evaluable metastatic disease to be eligible for the protocol. Patients with bilateral renal cancer are eligible as long as both cancers are of clear cell type and patients have metastatic or unresectable disease.
- Patients may have received up to two prior anti-cancer therapies (including receptor tyrosine kinase inhibitors or cytokine therapy) but no prior chemotherapy for renal cell carcinoma. Patients should have received prior standard therapy, or otherwise deemed ineligible for such therapies.
- Patients must have measurable or clinically evaluable disease as defined by RECIST criteria.
- Patients must be >/= 14 days beyond the last administration of anti-cancer therapy, and must have recovered from the toxicities of prior therapy.
- Patients must be >/= 18 years of age.
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- ECOG performance status </= 2 (Karnofsky >/= 60%).
- 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/microL; Platelets >/= 100,000/microL; Creatinine (serum) </= 2.0 mg/dL
- Patients without liver metastases: Total bilirubin </= 1.5 mg/dL; AST(SGOT)/ALT(SGPT) </= 2.5 X Institutional Upper Limit of Normal (IULN)
- Patients with liver metastases: Total bilirubin </= 1.5 x IULN; AST(SGOT)/ALT(SGPT) </= 5 x IULN
- The effects of decitabine and interferon on the developing human fetus are unknown. For this reason and because chemotherapy agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Female patients of childbearing potential should have a normal plasma beta human chorionic gonadotropin (betaHCG).
- 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.
Who cannot join
- Patients with active autoimmune disorders or who are receiving immunosuppressive therapy (including steroids or methotrexate) for any indication.
- Patients may not receive any other investigational agents within two 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 1 week prior to entering the study.
- Patients with untreated or symptomatic brain metastases.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or potentially life-threatening cardiac arrhythmia.
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- Psychiatric illness or social situations which in the opinion of the investigator could interfere with the completion of the proposed treatment.
- Pregnant women are excluded from this study because decitabine is an antimetabolite with the potential for teratogenic or abortifacient effects and interferon alfa-2b has abortifacient activity in animal studies. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine or decitabine and interferon.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, patients known to be HIV-positive and receiving anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with the study agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Interferon Alfa-2b in Advanced Renal Cell Carcinoma
Primary Objective:
- To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.
Read more
Secondary Objectives:
- To determine the toxicity of the combination of decitabine and interferon alfa-2b at the proposed dose and schedule in patients with advanced RCC
- To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.
- To determine the overall survival times for patients with advanced RCC treated with decitabine and interferon.
- To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene expression in patients' tumor and non-tumor tissues and their correlation with clinical outcomes.
- To characterize the modulation of cellular immunity induced by the combination of decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these results with clinical outcomes.
Read the detailed description
THE STUDY DRUGS:
Decitabine is designed to slow tumor growth and may cause death of cancer cells.
Interferon alfa-2B is designed to activate your immune system, which may help keep tumors from growing, and may shrink tumors.
STUDY TREATMENT:
If you are found to be eligible to take part in this study, you will receive decitabine by vein over 1 hour on Days 1-5 of each cycle. A cycle in this study is 28 days long. All treatments with decitabine will take place at M. D. Anderson.
Once you have completed 2 cycles of decitabine (on Day 1 of Cycle 3), you will begin taking interferon alfa-2b twice each day (morning and afternoon) while continuing the same 5-day dosing schedule for decitabine. Interferon alfa-2b will be given as a subcutaneous (just under the skin) injection. It can be given by yourself or a caregiver at home or by your local doctor. You and your caregiver will be taught how to do the injection.
STUDY VISITS:
You will have the following tests/procedures performed during clinic visits.
On Day 1 of each cycle:
- 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.
- You will have a performance status evaluation.
- You will be asked about any side effects you may have experienced since your last visit. You will have blood drawn (about 1 teaspoon) for routine testing.
Beginning in Cycle 3, you will be required to return to the clinic around Day 14 of each cycle to have the following tests:
- You will have blood drawn (about 1 teaspoon each time) once a week for routine tests. If you do not experience severe side effects during Cycles 3 and 4, you will no longer be required to have weekly routine blood testing. Instead, you will return to have routine blood drawn on Day 1 of each cycle. This once-weekly schedule will restart if you experience severe side effects in Cycle 5.
- You will have a CT or MRI scan to check the status of the disease.
- Your vital signs will be measured
- You will be asked about any side effects you may have experienced since your last visit.
LENGTH OF STUDY:
You will continue taking the study drug combination unless the disease gets worse, you develop an illness that does not allow you to continue receiving the study therapy, or you experience any intolerable side effects. If any of these things occur, you will be removed from this study.
This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Interferon alfa-2b is FDA approved and commercially available for the treatment of several types of cancer, such as malignant melanoma, hairy cell leukemia, and non-Hodgkin's lymphoma. Their use together in this study in the treatment of PRC is investigational and authorized for use in research only.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Decitabine, Interferon Alfa-2b
- Keywords
- Renal Cell Carcinoma, Renal Cell Cancer, Clear Cell, Kidney, Decitabine, Dacogen, 5-Aza-Deoxycytidine, Interferon Alfa-2b, Intron A®, RCC
- Medical subject headings
- Carcinoma, Renal Cell
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
15 mg/m^2 IV Daily over one hour for 5 days
Interferon Alfa-2bDrug
Also called Intron A®
0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one.
| Study group | Role | What they receive |
|---|---|---|
| Decitabine + Interferon Alfa-2b | Experimental | Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1. Receives: Drug: Decitabine; Drug: Interferon Alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) Times
Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.
Measured: From treatment start or until disease progression or death for any reason, at least 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2009
- Study completionNov 2009
Why it stopped: Low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Renal Cell CarcinomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Inc.
- Responsible party
- Sponsor
- Investigators
- Ana M. Aparicio, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561912
- Sponsor's protocol ID
- 2006-0962
- Status last verified
- Nov 2011
- First submitted
- 20 Nov 2007
- Last updated
- 26 Dec 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Low Dose Decitabine (5-Aza-Deoxycytidine) With Interferon Alfa-2b in Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00561912
- Acronym / sponsor ID
- 2006-0962
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma, Renal Cell Cancer, Clear Cell, Kidney, Decitabine, Dacogen, 5-Aza-Deoxycytidine, Interferon Alfa-2b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Eisai Inc.
- Study start
- Oct 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Posted 26 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- To determine the progression-free survival (PFS) times for patients with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b.
Secondary Objectives:
- To determine the toxicity of the combination of decitabine and interferon alfa-2b at the proposed dose and schedule in patients with advanced RCC
- To determine overall response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria for patients with advanced RCC treated with decitabine and interferon alfa-2b.
- To determine the overall survival times for patients with advanced RCC treated with decitabine and interferon.
- To study the effects of decitabine and interferon alfa-2b on DNA methylation and gene expression in patients' tumor and non-tumor tissues and their correlation with clinical outcomes.
- To characterize the modulation of cellular immunity induced by the combination of decitabine and interferon alfa-2b in patients with advanced RCC and to correlate these results with clinical outcomes.
Detailed description
THE STUDY DRUGS:
Decitabine is designed to slow tumor growth and may cause death of cancer cells.
Interferon alfa-2B is designed to activate your immune system, which may help keep tumors from growing, and may shrink tumors.
STUDY TREATMENT:
If you are found to be eligible to take part in this study, you will receive decitabine by vein over 1 hour on Days 1-5 of each cycle. A cycle in this study is 28 days long. All treatments with decitabine will take place at M. D. Anderson.
Once you have completed 2 cycles of decitabine (on Day 1 of Cycle 3), you will begin taking interferon alfa-2b twice each day (morning and afternoon) while continuing the same 5-day dosing schedule for decitabine. Interferon alfa-2b will be given as a subcutaneous (just under the skin) injection. It can be given by yourself or a caregiver at home or by your local doctor. You and your caregiver will be taught how to do the injection.
STUDY VISITS:
You will have the following tests/procedures performed during clinic visits.
On Day 1 of each cycle:
- 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.
- You will have a performance status evaluation.
- You will be asked about any side effects you may have experienced since your last visit. You will have blood drawn (about 1 teaspoon) for routine testing.
Beginning in Cycle 3, you will be required to return to the clinic around Day 14 of each cycle to have the following tests:
- You will have blood drawn (about 1 teaspoon each time) once a week for routine tests. If you do not experience severe side effects during Cycles 3 and 4, you will no longer be required to have weekly routine blood testing. Instead, you will return to have routine blood drawn on Day 1 of each cycle. This once-weekly schedule will restart if you experience severe side effects in Cycle 5.
- You will have a CT or MRI scan to check the status of the disease.
- Your vital signs will be measured
- You will be asked about any side effects you may have experienced since your last visit.
LENGTH OF STUDY:
You will continue taking the study drug combination unless the disease gets worse, you develop an illness that does not allow you to continue receiving the study therapy, or you experience any intolerable side effects. If any of these things occur, you will be removed from this study.
This is an investigational study. Decitabine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS). Interferon alfa-2b is FDA approved and commercially available for the treatment of several types of cancer, such as malignant melanoma, hairy cell leukemia, and non-Hodgkin's lymphoma. Their use together in this study in the treatment of PRC is investigational and authorized for use in research only.
Up to 60 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 + Interferon Alfa-2b | Experimental | Drug: Decitabine, Drug: Interferon Alfa-2bDecitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have histologically confirmed clear cell renal carcinoma that is metastatic or unresectable. In the absence of metastatic disease, patients who are deemed unresectable or inoperable will have a documented surgical opinion confirming this. Surgical opinion will be rendered either by surgical consultation or after presentation at our interdisciplinary conference. Patients with locally recurrent RCC are eligible, if surgical resection of local recurrence is not feasible or is refused by patient.
- Patients with locally advanced unresectable RCC should have measurable or evaluable metastatic disease to be eligible for the protocol. Patients with bilateral renal cancer are eligible as long as both cancers are of clear cell type and patients have metastatic or unresectable disease.
- Patients may have received up to two prior anti-cancer therapies (including receptor tyrosine kinase inhibitors or cytokine therapy) but no prior chemotherapy for renal cell carcinoma. Patients should have received prior standard therapy, or otherwise deemed ineligible for such therapies.
- Patients must have measurable or clinically evaluable disease as defined by RECIST criteria.
- Patients must be >/= 14 days beyond the last administration of anti-cancer therapy, and must have recovered from the toxicities of prior therapy.
Key exclusion criteria (9 listed)
- Patients with active autoimmune disorders or who are receiving immunosuppressive therapy (including steroids or methotrexate) for any indication.
- Patients may not receive any other investigational agents within two 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 1 week prior to entering the study.
- Patients with untreated or symptomatic brain metastases.
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, Dacogen15 mg/m^2 IV Daily over one hour for 5 days | Drug | Decitabine + Interferon Alfa-2b |
| Interferon Alfa-2bAlso: Intron A®0.5 million Units Subcutaneously Twice Daily Continuously. Interferon Alfa-2b will be added on cycle three, day one. | Drug | Decitabine + Interferon Alfa-2b |
Primary outcome
Progression-free Survival (PFS) Times
Time frame: From treatment start or until disease progression or death for any reason, at least 16 weeks
Progression-free survival (PFS) times for participants with advanced renal cell carcinoma (RCC) treated with decitabine and interferon alfa-2b where PFS is defined as starting from day one of the treatment combination to disease progression or death for any reason, measured in weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink 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.
Ana M. Aparicio, MD 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 2 study testing Decitabine and Interferon Alfa-2b in people with Renal Cell Carcinoma, 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 14 inclusion and 9 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 26 Dec 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 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?
Yes. Results are posted in the registry (first posted 26 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Progression-free Survival (PFS) Times (time frame: From treatment start or until disease progression or death for any reason, at least 16 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 26 Dec 2011.