Recurrent Classic Hodgkin LymphomaPhase 2NCT00967369
Combination Chemotherapy With or Without Bortezomib in Treating Patients With Classical Hodgkin Lymphoma That Has Returned or Does Not Respond to Prior Treatment.
A Phase 2 study testing Bortezomib, Carboplatin and Etoposide in people with Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies how well combination chemotherapy with or without bortezomib works in treating patients with classical Hodgkin lymphoma that has come back or does not respond to prior treatment. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Recurrent Classic Hodgkin Lymphoma, Refractory Classic Hodgkin 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2009to 2 May 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Relapsed or refractory classical Hodgkin lymphoma.
- Patients must have received a front-line standard anthracycline-containing regimen, such as adriamycin-bleomycin-vinblastine-dacarbazine (ABVD), Stanford V, or bleomycin-etoposide-adriamycin-cyclophosphamide-oncovin-procarbazine-prednisone (BEACOPP).
- Bi-dimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension.
- Absolute neutrophil count (ANC) >= 1,500/microL.
- Platelet count >= 100,000/ microL.
- Hemoglobin >= 8 g/dL.
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- Serum bilirubin < 2.0 mg/dL.
- Alkaline phosphatase < 2 x upper limits of normal (ULN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 x ULN.
- Serum creatinine =< 1.5 mg/dL.
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
- Females of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test and must agree to use 2 highly effective contraceptive methods (hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 3 months after completion of protocol treatment. Females of non-childbearing potential are those who are postmenopausal for greater than 1 year or whom have had a bilateral tubal ligation or hysterectomy.
- Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 3 months after completion of protocol treatment.
- Voluntary written informed consent 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.
Who cannot join
- Lymphocyte predominant Hodgkin lymphoma histology.
- More than one prior chemotherapy regimen.
- Prior autologous or allogeneic stem cell transplant.
- Presence of central nervous system (CNS) involvement with Hodgkin lymphoma.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
- Active hepatitis B or C infection or history of cirrhosis.
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- Grade 2 or greater peripheral neuropathy within 14 days of enrollment.
- 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 squamous intraepithelial lesion on PAP smear, or treated prostate cancer with a stable prostate specific antigen [PSA]) for which the patient has not been disease-free for at least 3 years.
- Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
- Patients with a myocardial infarction 6 months prior to enrollment, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiogram (ECG) evidence of acute ischemia or active conduction system abnormalities.
- Patient with other medical or psychiatric illness that is likely to interfere with participation in this clinical study.
- Female subject that is pregnant or breast-feeding.
- Patient that has received other investigational drugs within 14 days of enrollment.
- Patients using concurrent therapy with corticosteroids at greater than or equal to 20 mg/day of prednisone equivalent.
- Patients with active systemic bacterial, viral, or fungal infections that have required IV antimicrobials within 4 weeks prior to protocol treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
This phase II trial studies how well combination chemotherapy with or without bortezomib works in treating patients with classical Hodgkin lymphoma that has come back or does not respond to prior treatment. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib is designed to block a protein that plays a role in cell function and growth. Bortezomib may cause cancer cells to die. It is not yet known if combination chemotherapy with or without bortezomib may work better in treating patients with classical Hodgkin lymphoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the objective response rate (ORR), partial remissions (PR), and complete remissions (CR) after 3 cycles of bortezomib plus ifosfamide, carboplatin, and etoposide (ICE) (BICE) versus ICE in patients with relapsed/refractory classical Hodgkin lymphoma (cHL).
II. To evaluate 2-year progression-free survival (PFS) in patients treated with 3 cycles of BICE versus ICE.
SECONDARY OBJECTIVES:
- To compare positron emission tomography (PET) scan response after 3 cycles of BICE versus ICE chemotherapy.
II. To compare serum levels of tumor necrosis factor (TNF) proteins (a proliferation-inducing ligand [APRIL], B lymphocyte stimulator [BLyS], soluble [s]CD30, and CD40L) and CC thymus and activation-related cytokine (TARC) at baseline and after 3 cycles of BICE versus ICE chemotherapy.
III. To correlate baseline cytokine/chemokine levels with response to therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive bortezomib intravenously (IV) over 5 seconds on days 1 and 4, ifosfamide IV continuously over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on days 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive ifosfamide, carboplatin and etoposide as in Arm A. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years.
- Being tested
- Bortezomib, Carboplatin, Etoposide, Ifosfamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Also called [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341
Given IV
CarboplatinDrug
Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino
Given IV
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar
Given IV
IfosfamideDrug
Also called Asta Z 4942, Asta Z-4942, Cyfos, Holoxan
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm A (bortezomib, ifosfamide, carboplatin, etoposide) | Experimental | ARM A: Patients receive bortezomib IV over 5 seconds on days 1 and 4, ifosfamide IV continuously over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on days 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Bortezomib; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide |
| Arm B (ifosfamide, carboplatin, etoposide) | Active comparator | Patients receive ifosfamide, carboplatin and etoposide as in Arm A. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Response rates for Bortezomib, Ifosfamide, Carboplatin, Etoposide (BICE) and Ifosfamide, Carboplatin, Etoposide (ICE) treatment groups were assessed by the 1999 International Working Group (IWG)(CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: From baseline to 3 cycles of treatment
Progression Free Survival (PFS) Rate at 12 Months
Progression free survival time is defined as the time interval from treatment start to progression or death due to any cause whichever happens first. Participants will be censored at the last follow-up date, if an event(progression/death) is not observed during the follow-up.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Overall Survival (OS) Rate at 24 Months
Overall Survival is time from date of treatment start until date of death due to any cause or last Follow-up within 24 months.
Measured: 24 months
Secondary outcomes (3)
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy.
Response rates for BICE and ICE treatment groups will be assessed by 1999 IWG (CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria.
Measured: Baseline up to 1 year
Serum Levels of Tumor Necrosis Factor (TNF) Proteins (APRIL, BLyS, sCD30, and CD40L) and CC Thymus and Activation-related Cytokine (TARC) at Baseline and After 3 Cycles of BICE Versus ICE Chemotherapy
Measured: November 2009 and December 2010
Baseline Cytokine/Chemokine Levels With Response to Therapy.
Measured: 106 weeks/13 months/426 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study start24 Aug 2009
- Primary completion2 May 2018
- Study completion2 May 2018
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 Recurrent Classic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michelle Fanale, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00967369
- Sponsor's protocol ID
- 2008-0604
- Other IDs
- NCI-2018-02154, 2008-0604, P30CA016672
- Status last verified
- Apr 2020
- First submitted
- 25 Aug 2009
- Last updated
- 20 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Bortezomib Plus ICE (BICE) Versus Standard ICE for Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT00967369
- Acronym / sponsor ID
- 2008-0604
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Aug 2009 (actual)
- Primary completion
- 2 May 2018 (actual)
- Study completion
- 2 May 2018 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 20 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well combination chemotherapy with or without bortezomib works in treating patients with classical Hodgkin lymphoma that has come back or does not respond to prior treatment. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib is designed to block a protein that plays a role in cell function and growth. Bortezomib may cause cancer cells to die. It is not yet known if combination chemotherapy with or without bortezomib may work better in treating patients with classical Hodgkin lymphoma.
Detailed description
PRIMARY OBJECTIVES:
- To determine the objective response rate (ORR), partial remissions (PR), and complete remissions (CR) after 3 cycles of bortezomib plus ifosfamide, carboplatin, and etoposide (ICE) (BICE) versus ICE in patients with relapsed/refractory classical Hodgkin lymphoma (cHL).
II. To evaluate 2-year progression-free survival (PFS) in patients treated with 3 cycles of BICE versus ICE.
SECONDARY OBJECTIVES:
- To compare positron emission tomography (PET) scan response after 3 cycles of BICE versus ICE chemotherapy.
II. To compare serum levels of tumor necrosis factor (TNF) proteins (a proliferation-inducing ligand [APRIL], B lymphocyte stimulator [BLyS], soluble [s]CD30, and CD40L) and CC thymus and activation-related cytokine (TARC) at baseline and after 3 cycles of BICE versus ICE chemotherapy.
III. To correlate baseline cytokine/chemokine levels with response to therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive bortezomib intravenously (IV) over 5 seconds on days 1 and 4, ifosfamide IV continuously over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on days 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive ifosfamide, carboplatin and etoposide as in Arm A. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 4 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (bortezomib, ifosfamide, carboplatin, etoposide) | Experimental | Drug: Bortezomib, Drug: Carboplatin, Drug: Etoposide, Drug: IfosfamideARM A: Patients receive bortezomib IV over 5 seconds on days 1 and 4, ifosfamide IV continuously over 24 hours on day 1, carboplatin IV over 1 hour on day 1, and etoposide IV over 2 hours on days 1-3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
| Arm B (ifosfamide, carboplatin, etoposide) | Active comparator | Drug: Carboplatin, Drug: Etoposide, Drug: IfosfamidePatients receive ifosfamide, carboplatin and etoposide as in Arm A. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Relapsed or refractory classical Hodgkin lymphoma.
- Patients must have received a front-line standard anthracycline-containing regimen, such as adriamycin-bleomycin-vinblastine-dacarbazine (ABVD), Stanford V, or bleomycin-etoposide-adriamycin-cyclophosphamide-oncovin-procarbazine-prednisone (BEACOPP).
- Bi-dimensionally measurable disease with at least 1 lesion >= 2.0 cm in a single dimension.
- Absolute neutrophil count (ANC) >= 1,500/microL.
- Platelet count >= 100,000/ microL.
Key exclusion criteria (17 listed)
- Lymphocyte predominant Hodgkin lymphoma histology.
- More than one prior chemotherapy regimen.
- Prior autologous or allogeneic stem cell transplant.
- Presence of central nervous system (CNS) involvement with Hodgkin lymphoma.
- Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
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: [(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid, LDP 341, MLN341, PS-341Given IV | Drug | Arm A (bortezomib, ifosfamide, carboplatin, etoposide) |
| CarboplatinAlso: Blastocarb, Carboplat, Carboplatin Hexal, CarboplatinoGiven IV | Drug | Arm A (bortezomib, ifosfamide, carboplatin, etoposide), Arm B (ifosfamide, carboplatin, etoposide) |
| EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, ToposarGiven IV | Drug | Arm A (bortezomib, ifosfamide, carboplatin, etoposide), Arm B (ifosfamide, carboplatin, etoposide) |
| IfosfamideAlso: Asta Z 4942, Asta Z-4942, Cyfos, HoloxanGiven IV | Drug | Arm A (bortezomib, ifosfamide, carboplatin, etoposide), Arm B (ifosfamide, carboplatin, etoposide) |
Primary outcome
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma
Time frame: From baseline to 3 cycles of treatment
Response rates for Bortezomib, Ifosfamide, Carboplatin, Etoposide (BICE) and Ifosfamide, Carboplatin, Etoposide (ICE) treatment groups were assessed by the 1999 International Working Group (IWG)(CT alone) (Cheson et al., 1999) and compared to 2007 IWG (CT plus PET) (Cheson et al., 2007) criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Progression Free Survival (PFS) Rate at 12 Months
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Progression free survival time is defined as the time interval from treatment start to progression or death due to any cause whichever happens first. Participants will be censored at the last follow-up date, if an event(progression/death) is not observed during the follow-up.
Overall Survival (OS) Rate at 24 Months
Time frame: 24 months
Overall Survival is time from date of treatment start until date of death due to any cause or last Follow-up within 24 months.
3 secondary outcomes
PET Scan Response After 3 Cycles of BICE Versus ICE Chemotherapy.
Time frame: Baseline up to 1 year
Serum Levels of Tumor Necrosis Factor (TNF) Proteins (APRIL, BLyS, sCD30, and CD40L) and CC Thymus and Activation-related Cytokine (TARC) at Baseline and After 3 Cycles of BICE Versus ICE Chemotherapy
Time frame: November 2009 and December 2010
Baseline Cytokine/Chemokine Levels With Response to Therapy.
Time frame: 106 weeks/13 months/426 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Michelle Fanale 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 Bortezomib, Carboplatin and Etoposide in people with Recurrent Classic Hodgkin Lymphoma and Refractory Classic Hodgkin 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 14 inclusion and 17 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 20 Apr 2020. 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 20 Apr 2020). 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?
Overall Response After 3 Cycles of Botezomib Plus ICE (BICE) Versus Ifosfamide, Carboplatin, Etoposide (ICE) in Patients With Relapsed/Refractory Classical Hodgkin Lymphoma (time frame: From baseline to 3 cycles of treatment). The study lists 3 primary outcomes in all. 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 20 Apr 2020.