Hodgkin LymphomaPhase 1NCT00439361
Velcade Plus ICE for Patients With Relapsed Classical Hodgkin Lymphoma
A Phase 1 study testing Bortezomib, Carboplatin and Etoposide in people with Hodgkin Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL). 2. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hodgkin Lymphoma, Lymphoma
- What is being tested?
- Bortezomib, Carboplatin and Etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2012
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed relapsed or refractory classical Hodgkin lymphoma (nodular sclerosis, mixed cellularity, or lymphocyte-rich classical HL).
- Patients must have failed front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
- Bidimensionally measurable disease with at least 1 lesion >/= 2.0 cm in a single dimension
- Acceptable hematologic status: Hemoglobin >/= 8.0 g/dL; Absolute neutrophil count >/= 1500 cells/mm^3; Platelet count >/= 100,000 cells/mm^3
- Pre-study World Health Organization (WHO) performance status of 0, 1, or 2
- Age greater than or equal to 16 years
- Voluntary signed IRB approved consent informed before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- Patients of reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Male subject agrees to use an acceptable method for contraception for the duration of the study. Female patients must not be pregnant or lactating.
Who cannot join
- Lymphocyte predominant histology
- More than one prior chemotherapy regimen.
- Prior stem cell transplant
- Abnormal liver function:Bilirubin > 2.0 mg/dL (26 µmol/L); Alkaline phosphatase > 2 * upper limits of normal (ULN); AST (SGOT) > 2 * ULN
- Serum creatinine > 1.5 mg/dL (177 µmol/L) within 14 days before enrollment
- Presence of CNS involvement with Hodgkin lymphoma
Show all 16Show fewer
- Presence of HIV infection or AIDS
- Patient has >/= Grade 2 peripheral neuropathy within 14 days before enrollment.
- Patient has hypersensitivity to boron or mannitol.
- Prior bortezomib therapy.
- Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
- Serious nonmalignant disease (e.g., congestive heart failure, hydronephrosis); active uncontrolled bacterial, viral, or fungal infections; or other conditions which would compromise protocol objectives in the opinion of the investigator and/or the sponsor.
- Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women.
- Patient has received other investigational drugs with 14 days before enrollment
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase-I Study of Bortezomib (VELCADE) Plus ICE (Ifosfamide, Carboplatin, Etoposide) for Patients With Relapsed Classical Hodgkin Lymphoma
Primary Objectives:
- To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
- To determine the maximum tolerated dose (MTD) of bortezomib when given in combination with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
Secondary Objectives:
- To determine the overall response rate and complete response rate in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
Read the detailed description
Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die.
ICE is a combination of chemotherapy drugs that, together, may work more effectively at causing cancer cells to die by stopping cells from dividing.
Mesna is a drug that protects bladder cells from damage by the chemotherapy drug ifosfamide. It is used to decrease the risk of bleeding in the bladder.
Before you can start taking the drugs on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. These tests may be performed within 28 days of starting the study drugs. If you have had some of these exams, tests, or procedures performed recently, they may not need to be repeated. This will be for your study doctor to decide. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight. You will have x-rays and a bone marrow biopsy to check the status of the disease. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. You will have a computed tomography (CT) scan of your abdomen, chest, and pelvis and a positron emission tomography (PET) scan. Blood (about 2-3 tablespoons) will be drawn for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test within 1 month before starting therapy on this study. Because taking part in this study requires that participants' ability to fight off infections be normal, you will have blood drawn (about 1-2 tablespoons) to be tested for HIV within 6 months before starting therapy on this study. If your HIV test results are found to be positive, you will not be able to take part in this study.
All participants will receive bortezomib as a fixed dose, which will not change unless any intolerable side effects occur. At the start of this study, 3 participants will be given a dose of bortezomib. If this dose does not cause intolerable side effects, the dose will be increased as new participants take part in this study. There will be a total of 3 groups (with 3-6 participants per group) entered at increasing dose levels. The dose of bortezomib you receive will depend on when you join this study.
If you are found to be eligible to take part in this study, you will receive bortezomib plus ICE by vein. You will receive bortezomib, on Days 1 and 4, over 5 seconds. The ICE regimen will be given as a continuous infusion over different times as follows. On Day 1, you will receive ifosfamide and mesna over 24 hours. On Day 2, you will receive mesna over 12 hours and carboplatin over 1 hour. On Days 1-3, you will receive etoposide over 2 hours. This schedule for bortezomib plus ICE is considered 1 cycle (2 weeks) and will be repeated every 14 days.
You may have 3-6 cycles of the study drugs, depending on your tolerance of the drugs and the status of the disease. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
Blood (about 2-3 tablespoons) will be drawn once a week for routine tests. You will have a study visit before the start of each 2-week cycle. During these visits, you will have a brief questionnaire that will ask about specific side effects you might be experiencing. It should take about 5 minutes to complete this questionnaire.
After completing 3 cycles, you will return for CT scans, bone marrow biopsies (if they were positive for disease before you began on this study), and a PET scan to check the status of the disease.
After completing 3 cycles (if the disease did not worsen and intolerable side effects did not occur), you may continue on this study for 3 more cycles. During Cycles 4-6, you will have the same scans and blood tests as mentioned above.
After completing this study, for every 3-4 months on an indefinite basis, you will have follow-up visits. During these visits, you will have blood drawn (about 2-3 tablespoons) for routine tests. You will also have the same scans that were performed during the screening visit.
This is an investigational study. Bortezomib and ICE are FDA approved and commercially available. The combination of bortezomib plus ICE is considered investigational and authorized for use in research only.
Up to 18 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Hodgkin Lymphoma, Lymphoma
- Being tested
- Bortezomib, Carboplatin, Etoposide, Ifosfamide, Mesna
- Keywords
- Hodgkin Lymphoma, HL, Relapsed Classical Hodgkin Lymphoma, Refractory, Lymphoma, Nodular sclerosis, Mixed cellularity, Lymphocyte-rich classical HL, Bortezomib, Velcade, LDP-341, MLN341, PS-341, Carboplatin, Paraplatin, Etoposide, VePesid®, Ifosfamide, Mesna, Mesnex
- Medical subject headings
- Hodgkin Disease, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called Velcade, LDP-341, MLN341, PS-341
1.0 mg/m^2 by Vein Over 5 Seconds on Days 1 and 4
CarboplatinDrug
Also called Paraplatin®
5 AUC by Vein Over 1 Hour On Day 1
EtoposideDrug
Also called VePesid®
100 mg/m^2 By Vein Over 2 Hours On Days 1-3
IfosfamideDrug
5 Gm/m^2 By Vein Continuous Infusion Over 24 Hours On Day 1
MesnaDrug
Also called Mesnex
5 mg/m^2 IV continuous Infusion over 24 Hours On Day 1; 2 Gm/m^2 IV continuous infusion over 12 hours starting after completion of Ifosfamide + Mesna 24 hour continuous infusion
| Study group | Role | What they receive |
|---|---|---|
| Bortezomib + ICE | Experimental | Bortezomib + ICE (Ifosfamide, Carboplatin, Etoposide):
Bortezomib 1.0 mg/m^2 intravenous (IV) over 5 Seconds on Days 1 and 4; + ICE (Ifosfamide 5 Gm/m^2 IV continuous infusion on Day 1, Carboplatin 5 AUC IV over 1 Hour Day 1, Etoposide 100 mg/m^2 IV over 2 Hours Days 1-3) + Mesna 5 mg/m^2 IV continuous infusion Day 1; 2 Gm/m^2 IV continuous infusion over 12 Hours. Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerable Dose (MTD) of Bortezomib when given in combination with ICE chemotherapy in participants with relapsed and refractory classical Hodgkin lymphoma (HL)
MTD dose escalation stops either at the highest indicated dose of bortezomib (1.5 mg/m2), or when a Dose limiting toxicity (DLT) has been observed in at least one third of the patients at any dose level.
Measured: Two-week cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin LymphomaStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Michelle A. Fanale, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439361
- Sponsor's protocol ID
- 2006-0527
- Status last verified
- Jul 2012
- First submitted
- 22 Feb 2007
- Last updated
- 9 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase-I Study of Bortezomib (VELCADE) Plus ICE (Ifosfamide, Carboplatin, Etoposide) for Patients With Relapsed Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00439361
- Acronym / sponsor ID
- 2006-0527
- Conditions
- Hodgkin Lymphoma, Lymphoma
- Keywords
- Hodgkin Lymphoma, HL, Relapsed Classical Hodgkin Lymphoma, Refractory, Lymphoma, Nodular sclerosis, Mixed cellularity, Lymphocyte-rich classical HL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Millennium Pharmaceuticals, Inc.
- Study start
- Feb 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Feb 2007 (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.
Primary Objectives:
- To determine the toxicity profile of multiple doses of bortezomib when given with ICE in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
- To determine the maximum tolerated dose (MTD) of bortezomib when given in combination with ICE chemotherapy in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
Secondary Objectives:
- To determine the overall response rate and complete response rate in patients with relapsed and refractory classical Hodgkin lymphoma (HL).
Detailed description
Bortezomib is designed to block a protein that plays a role in cell function and growth, which may cause cancer cells to die.
ICE is a combination of chemotherapy drugs that, together, may work more effectively at causing cancer cells to die by stopping cells from dividing.
Mesna is a drug that protects bladder cells from damage by the chemotherapy drug ifosfamide. It is used to decrease the risk of bleeding in the bladder.
Before you can start taking the drugs on this study, you will have "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. These tests may be performed within 28 days of starting the study drugs. If you have had some of these exams, tests, or procedures performed recently, they may not need to be repeated. This will be for your study doctor to decide. You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate), height, and weight. You will have x-rays and a bone marrow biopsy to check the status of the disease. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. You will have a computed tomography (CT) scan of your abdomen, chest, and pelvis and a positron emission tomography (PET) scan. Blood (about 2-3 tablespoons) will be drawn for routine tests. Women who are able to have children must have a negative blood (about 1 teaspoon) pregnancy test within 1 month before starting therapy on this study. Because taking part in this study requires that participants' ability to fight off infections be normal, you will have blood drawn (about 1-2 tablespoons) to be tested for HIV within 6 months before starting therapy on this study. If your HIV test results are found to be positive, you will not be able to take part in this study.
All participants will receive bortezomib as a fixed dose, which will not change unless any intolerable side effects occur. At the start of this study, 3 participants will be given a dose of bortezomib. If this dose does not cause intolerable side effects, the dose will be increased as new participants take part in this study. There will be a total of 3 groups (with 3-6 participants per group) entered at increasing dose levels. The dose of bortezomib you receive will depend on when you join this study.
If you are found to be eligible to take part in this study, you will receive bortezomib plus ICE by vein. You will receive bortezomib, on Days 1 and 4, over 5 seconds. The ICE regimen will be given as a continuous infusion over different times as follows. On Day 1, you will receive ifosfamide and mesna over 24 hours. On Day 2, you will receive mesna over 12 hours and carboplatin over 1 hour. On Days 1-3, you will receive etoposide over 2 hours. This schedule for bortezomib plus ICE is considered 1 cycle (2 weeks) and will be repeated every 14 days.
You may have 3-6 cycles of the study drugs, depending on your tolerance of the drugs and the status of the disease. If the disease gets worse or you experience any intolerable side effects, you will be taken off this study.
Blood (about 2-3 tablespoons) will be drawn once a week for routine tests. You will have a study visit before the start of each 2-week cycle. During these visits, you will have a brief questionnaire that will ask about specific side effects you might be experiencing. It should take about 5 minutes to complete this questionnaire.
After completing 3 cycles, you will return for CT scans, bone marrow biopsies (if they were positive for disease before you began on this study), and a PET scan to check the status of the disease.
After completing 3 cycles (if the disease did not worsen and intolerable side effects did not occur), you may continue on this study for 3 more cycles. During Cycles 4-6, you will have the same scans and blood tests as mentioned above.
After completing this study, for every 3-4 months on an indefinite basis, you will have follow-up visits. During these visits, you will have blood drawn (about 2-3 tablespoons) for routine tests. You will also have the same scans that were performed during the screening visit.
This is an investigational study. Bortezomib and ICE are FDA approved and commercially available. The combination of bortezomib plus ICE is considered investigational and authorized for use in research only.
Up to 18 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 |
|---|---|---|
| Bortezomib + ICE | Experimental | Drug: Bortezomib, Drug: Carboplatin, Drug: Etoposide, Drug: Ifosfamide, Drug: MesnaBortezomib + ICE (Ifosfamide, Carboplatin, Etoposide): Bortezomib 1.0 mg/m^2 intravenous (IV) over 5 Seconds on Days 1 and 4; + ICE (Ifosfamide 5 Gm/m^2 IV continuous infusion on Day 1, Carboplatin 5 AUC IV over 1 Hour Day 1, Etoposide 100 mg/m^2 IV over 2 Hours Days 1-3) + Mesna 5 mg/m^2 IV continuous infusion Day 1; 2 Gm/m^2 IV continuous infusion over 12 Hours. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed relapsed or refractory classical Hodgkin lymphoma (nodular sclerosis, mixed cellularity, or lymphocyte-rich classical HL).
- Patients must have failed front-line standard anthracycline-containing regimen, such as ABVD, Stanford V, or BEACOPP.
- Bidimensionally measurable disease with at least 1 lesion >/= 2.0 cm in a single dimension
- Acceptable hematologic status: Hemoglobin >/= 8.0 g/dL; Absolute neutrophil count >/= 1500 cells/mm^3; Platelet count >/= 100,000 cells/mm^3
- Pre-study World Health Organization (WHO) performance status of 0, 1, or 2
Key exclusion criteria (16 listed)
- Lymphocyte predominant histology
- More than one prior chemotherapy regimen.
- Prior stem cell transplant
- Abnormal liver function:Bilirubin > 2.0 mg/dL (26 µmol/L); Alkaline phosphatase > 2 * upper limits of normal (ULN); AST (SGOT) > 2 * ULN
- Serum creatinine > 1.5 mg/dL (177 µmol/L) within 14 days before enrollment
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 |
|---|---|---|
| BortezomibAlso: Velcade, LDP-341, MLN341, PS-3411.0 mg/m^2 by Vein Over 5 Seconds on Days 1 and 4 | Drug | Bortezomib + ICE |
| CarboplatinAlso: Paraplatin®5 AUC by Vein Over 1 Hour On Day 1 | Drug | Bortezomib + ICE |
| EtoposideAlso: VePesid®100 mg/m^2 By Vein Over 2 Hours On Days 1-3 | Drug | Bortezomib + ICE |
| Ifosfamide5 Gm/m^2 By Vein Continuous Infusion Over 24 Hours On Day 1 | Drug | Bortezomib + ICE |
| MesnaAlso: Mesnex5 mg/m^2 IV continuous Infusion over 24 Hours On Day 1; 2 Gm/m^2 IV continuous infusion over 12 hours starting after completion of Ifosfamide + Mesna 24 hour continuous infusion | Drug | Bortezomib + ICE |
Primary outcome
Maximum Tolerable Dose (MTD) of Bortezomib when given in combination with ICE chemotherapy in participants with relapsed and refractory classical Hodgkin lymphoma (HL)
Time frame: Two-week cycle
MTD dose escalation stops either at the highest indicated dose of bortezomib (1.5 mg/m2), or when a Dose limiting toxicity (DLT) has been observed in at least one third of the patients at any dose level.
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 9 Jul 2012.
- UT 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.
Michelle A. Fanale, 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 1 study testing Bortezomib, Carboplatin and Etoposide in people with Hodgkin Lymphoma and Lymphoma, 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 8 inclusion and 16 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 9 Jul 2012. 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?
Maximum Tolerable Dose (MTD) of Bortezomib when given in combination with ICE chemotherapy in participants with relapsed and refractory classical Hodgkin lymphoma (HL) (time frame: Two-week cycle). 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 Jul 2012.