Adult Lymphocyte Depletion Hodgkin LymphomaPhase 2NCT00082966
Bortezomib in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma
A Phase 2 study testing 17-N-allylamino-17-demethoxygeldanamycin/bortezomib in people with Adult Lymphocyte Depletion Hodgkin Lymphoma and Adult Mixed Cellularity Hodgkin Lymphoma, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma
- What is being tested?
- 17-N-allylamino-17-demethoxygeldanamycin/bortezomib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Mar 2007
- Phase
- Phase 2
- 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
- Histologically confirmed classical Hodgkin's lymphoma
- No bone marrow biopsies or fine needle aspirates as the sole means of diagnosis
- Core biopsies allowed if they contain adequate tissue for primary diagnosis
- The following subtypes are allowed:
- Nodular sclerosis
- Lymphocyte rich
Show all 41Show fewer
- Mixed cellularity
- Lymphocyte depletion
- Classical Hodgkin's lymphoma, not otherwise specified
- No nodular lymphocyte-predominant Hodgkin's lymphoma
- Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen
- Measurable disease by physical exam or imaging studies
- Any tumor mass > 1 cm is allowed
- No non-measurable disease only, including the following:
- Bone lesions
- Ascites
- Pleural or pericardial effusion
- Lymphangitis cutis/pulmonis
- Bone marrow
- No curative option available with high-dose therapy and stem cell transplantation
- Performance status - 0-2
- Absolute neutrophil count ≥ 750/mm^3
- Platelet count ≥ 75,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST ≤ 2.5 times ULN
- Creatinine ≤ 2.5 mg/dL
- No sensory or motor peripheral neuropathy ≥ grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for up to 3 months after study participation
- See Disease Characteristics
- Prior stem cell transplantation allowed
- See Disease Characteristics
- No concurrent chemotherapy
- No concurrent dexamethasone or other steroidal antiemetics
- Concurrent steroids for adrenal failure allowed
- Concurrent hormonal therapy for non-disease related conditions (e.g., insulin for diabetes) allowed
- Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) is allowed provided other measurable disease is present
- No concurrent palliative radiotherapy
- Recovered from all prior treatment
- No prior bortezomib or other proteosome inhibitors
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint.
II. To assess time to progression and 2-year overall survival after bortezomib therapy.
III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
- Conditions
- Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma
- Being tested
- 17-N-allylamino-17-demethoxygeldanamycin/bortezomib
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-N-allylamino-17-demethoxygeldanamycin/bortezomibDrug
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity. Receives: Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: Up to 3 years
Time to progression
Measured: Up to 5 years
Overall survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2004 (estimated)
- Study startMar 2004
- Primary completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Lymphocyte Depletion Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Nancy Bartlett, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00082966
- Sponsor's protocol ID
- NCI-2012-01812
- Other IDs
- CALGB-50206, CDR0000361745, U10CA031946
- Status last verified
- Jun 2013
- First submitted
- 14 May 2004
- Last updated
- 4 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of PS-341 (Bortezomib) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00082966
- Acronym / sponsor ID
- NCI-2012-01812
- Conditions
- Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Mar 2004
- Primary completion
- Mar 2007 (actual)
- First posted
- 17 May 2004 (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.
Phase II trial to study the effectiveness of bortezomib in treating patients who have relapsed or refractory Hodgkin's lymphoma. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the efficacy of bortezomib in patients with relapsed or refractory Hodgkin's lymphoma using overall response rate as the primary efficacy endpoint.
II. To assess time to progression and 2-year overall survival after bortezomib therapy.
III. To evaluate the safety and tolerability of bortezomib in patients with relapsed/refractory Hodgkin's lymphoma.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: 17-N-allylamino-17-demethoxygeldanamycin/bortezomibPatients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of rapid disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (41 listed)
- Histologically confirmed classical Hodgkin's lymphoma
- The following subtypes are allowed:
- No nodular lymphocyte-predominant Hodgkin's lymphoma
- Relapsed or refractory disease after at least 1 prior standard systemic cytotoxic chemotherapy regimen
- Measurable disease by physical exam or imaging studies
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 17-N-allylamino-17-demethoxygeldanamycin/bortezomibGiven IV | Drug | Arm I |
Primary outcome
Overall response rate
Time frame: Up to 3 years
Time to progression
Time frame: Up to 5 years
Overall survival
Time frame: 2 years
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 4 Dec 2015.
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.
Nancy Bartlett principal investigator
Cancer and Leukemia Group B
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 17-N-allylamino-17-demethoxygeldanamycin/bortezomib in people with Adult Lymphocyte Depletion Hodgkin Lymphoma and Adult Mixed Cellularity Hodgkin Lymphoma, run by National Cancer Institute (NCI) 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 41 inclusion and 0 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 4 Dec 2015. 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?
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?
Overall response rate (time frame: Up to 3 years). 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 4 Dec 2015.