LymphomaPhase 1NCT00293488
SL-11047 in Treating Patients With Relapsed or Refractory Lymphoma
A Phase 1 study testing polyamine analogue PG11047 in people with Lymphoma, run by Progen Pharmaceuticals at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- polyamine analogue PG11047
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically* confirmed Hodgkin's or non-Hodgkin's lymphoma (NHL) of any histology
- The following NHL types are eligible:
- Diffuse large B-cell lymphoma
- Follicular lymphoma
- Mantle Cell lymphoma
- Marginal zone lymphoma (including lymphoma of mucosa-associated tissue [MALT])
- Anaplastic large cell lymphoma
- Peripheral T-cell lymphoma
- Cutaneous T-cell lymphoma
- T/NK cell lymphoma
- Angioimmunoblastic lymphadenopathy-type T-cell lymphoma
- Burkitt's lymphoma NOTE: * If histologic confirmation was made at initial diagnosis, confirmation of relapsed or refractory disease can be made by repeat histologic evaluation OR by evidence of regrowth at a site of disease that was previously histologically confirmed
- Relapsed after or refractory to ≥ 2 prior therapeutic regimens OR patient is ineligible to receive potentially curative therapy
- Bidimensionally measurable or evaluable (e.g., bone marrow or infiltrative organ involvement) disease by physical exam or radiographic study
- No suspicion or evidence of lymphomatous meningitis
PATIENT CHARACTERISTICS:
- Life expectancy ≥ 12 weeks
- ECOG performance status 0-4
- Not pregnant
- Negative pregnancy test
- Fertile patients must use medically prescribed contraception
- Absolute neutrophil count ≥ 1,000/mm^3*
- Platelet count ≥ 50,000/mm^3*
- Hemoglobin ≥ 8 g/dL*
- Serum creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 2.0 mg/dL**
- Transaminases < 5 times upper limit of normal**
- No other malignancy within the past 5 years other than curatively treated non-metastatic skin cancer or in situ cervical carcinoma
- No history of significant or symptomatic cardiac arrhythmia
- No history of myocardial infarction
- No significant ventricular conduction abnormality by ECG or Holter monitoring, as evidenced by any of the following:
- Prior myocardial infarction
- Three or more premature ventricular contractions in a row
- No history of pancreatitis
- No history of recent gastrointestinal bleeding
- Must have heme-negative stool at enrollment NOTE: *Cytopenias due to direct lymphomatous involvement allowed
NOTE: **Elevated due to direct lymphomatous involvement allowed
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 3 weeks since prior chemotherapy
- Recovered from prior chemotherapy (alopecia or anemia allowed)
- More than 3 weeks since prior investigational drugs
- No prophylactic antiemetics during course 1
- No other concurrent investigational drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma
RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of SL-11047 in patients with relapsed or refractory lymphoma.
- Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or refractory lymphoma.
Secondary
- Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion.
- Assess the response rate and duration of response in patients treated with SL-11047.
- Assess the level of SL-11047 within tumor tissues following intravenous administration of the drug.
- Determine the sensitivity of abnormal circulating macrophages to SL-11047.
OUTLINE: This is an open-label, nonrandomized, dose-escalation study.
Patients receive SL-11047 IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SL-11047 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- polyamine analogue PG11047
- Keywords
- anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult T-cell leukemia/lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent mycosis fungoides/Sezary syndrome, splenic marginal zone lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large-Cell, Anaplastic, Immunoblastic Lymphadenopathy, Lymphoma, B-Cell, Marginal Zone, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Hodgkin Disease, Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyamine analogue PG11047Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Progen Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara Hicks, Progen Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293488
- Sponsor's protocol ID
- PROGEN-SL002
- Other IDs
- CDR0000463738, UCSF-H1956-21906-02, UCSF-SL002
- Status last verified
- Jun 2016
- First submitted
- 16 Feb 2006
- Last updated
- 23 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I Study Evaluating Safety, Tolerability and Pharmacokinetics of SL-11047 in Patients With Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT00293488
- Acronym / sponsor ID
- PROGEN-SL002
- Conditions
- Lymphoma
- Keywords
- anaplastic large cell lymphoma, angioimmunoblastic T-cell lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult T-cell leukemia/lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Progen PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2006
- Primary completion
- Sep 2008 (actual)
- First posted
- 17 Feb 2006 (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.
RATIONALE: Drugs used in chemotherapy, such as SL-11047, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of SL-11047 in treating patients with relapsed or refractory lymphoma.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of SL-11047 in patients with relapsed or refractory lymphoma.
- Describe and quantify the toxicity of SL-11047 administered to patients with relapsed or refractory lymphoma.
Secondary
- Describe the pharmacokinetics of SL-11047 administered as a 30-minute IV infusion.
- Assess the response rate and duration of response in patients treated with SL-11047.
- Assess the level of SL-11047 within tumor tissues following intravenous administration of the drug.
- Determine the sensitivity of abnormal circulating macrophages to SL-11047.
OUTLINE: This is an open-label, nonrandomized, dose-escalation study.
Patients receive SL-11047 IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of SL-11047 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| polyamine analogue PG11047 | Drug | – |
Primary outcome
Not reported in the source record.
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 23 Jun 2016.
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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.
Barbara Hicks
Progen Pharmaceuticals
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 polyamine analogue PG11047 in people with Lymphoma, run by Progen Pharmaceuticals 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?
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 23 Jun 2016. 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.
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 23 Jun 2016.