LymphomaPhase 1NCT00053105
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
A Phase 1 study testing cisplatin, cytarabine and methylprednisolone in people with Lymphoma, run by Theradex at 7 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory… Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- cisplatin, cytarabine and methylprednisolone
- How many people
- Not given
- Where
- 7 sitesUnited States
- Study dates
- Feb 2002to not given
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) including the following:
- Diffuse large B-cell lymphoma
- Transformed NHL
- Follicular large cell lymphoma
- Peripheral T-cell lymphoma
- Unclassified aggressive histology (immunoblastic lymphoma)
- Must have received 1 to 3 prior chemotherapy treatment regimens (may include doxorubicin up to a cumulative dose of no greater than 450 mg/m^2)
- No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 to 64
Performance status
- WHO 0-1
Life expectancy
- At least 3 months
Hematopoietic
- Neutrophil count at least 1,500/mm^3*
- Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if evidence of bone marrow involvement
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)**
- Alkaline phosphatase no greater than 2 times ULN**
- AST or ALT no greater than 2 times ULN**
- No history or clinical symptoms of hepatitis B or C virus NOTE: **Higher values may be accepted if evidence of liver involvement
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- LVEF at least 50% by MUGA
- No clinically significant cardiovascular abnormalities
- No New York Heart Association class II-IV heart disease
- No myocardial infarction within the past 6 months
- No severe arrhythmia
- No uncontrolled hypertension
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study
- No history or clinical symptoms of HIV
- No clinically significant neurological abnormalities
- No serious uncontrolled infection (NCI CTC grade 3-4)
- No condition that would place the patient at undue risk or interfere with the study results
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior radioimmunotherapy
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- At least 1 year since prior platinum or cytarabine (unless complete response to treatment)
- At least 2 years since prior fludarabine or nitrosoureas
- No prior cumulative cisplatin greater than 600 mg/m^2
Endocrine therapy
- Not specified
Radiotherapy
- See Biologic therapy
- At least 4 weeks since prior radiotherapy
- No prior radiotherapy to the whole pelvis
Surgery
- At least 1 week since prior minor surgery and recovered
- At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered
Other
- At least 1 month since prior investigational drugs
- Recovered from prior therapy
- No other concurrent investigational drugs
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
Ireland Cancer Center
Cleveland, Ohio, 44106-5055
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0800
Boston Baskin Cancer Group, University Tennessee
Memphis, Tennessee, 38104
Highlands Oncology Group
Springdale, Arkansas, 72764
Arizona Clinical Research Center
Tucson, Arizona, 85712
About this study
Official title: A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and recommended dose of pixantrone when administered with cytarabine, methylprednisolone, and cisplatin in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Determine the relationship between toxicity and systemic exposure to this regimen in these patients.
- Determine the safety of this regimen in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the efficacy of this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of pixantrone.
Patients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is defined as the dose preceding the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- cisplatin, cytarabine, methylprednisolone, pixantrone dimaleate
- Keywords
- recurrent adult diffuse large cell lymphoma, recurrent grade 3 follicular lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, T-Cell, Cutaneous, Lymphoma, Large-Cell, Immunoblastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatinDrug
cytarabineDrug
pixantrone dimaleateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startFeb 2002
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
Sponsor and investigators
- Lead sponsor
- Theradex
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luis Fayad, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053105
- Sponsor's protocol ID
- CDR0000269140
- Other IDs
- THERADEX-AZA-I-05, NOVUSPHARMA-AZA-I-05, NOVUSPHARMA-AZA-1401, CWRU-050213J
- Status last verified
- Mar 2003
- First submitted
- 27 Jan 2003
- Last updated
- 7 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00053105
- Acronym / sponsor ID
- CDR0000269140
- Conditions
- Lymphoma
- Keywords
- recurrent adult diffuse large cell lymphoma, recurrent grade 3 follicular lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- TheradexIndustry (pharma, biotech, devices)
- Study start
- Feb 2002
- First posted
- 28 Jan 2003 (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 use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effect of combination chemotherapy on the body when treating patients who have relapsed or refractory aggressive non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose and recommended dose of pixantrone when administered with cytarabine, methylprednisolone, and cisplatin in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma.
- Determine the dose-limiting toxic effects of this regimen in these patients.
- Determine the relationship between toxicity and systemic exposure to this regimen in these patients.
- Determine the safety of this regimen in these patients.
- Assess the pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the efficacy of this regimen in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of pixantrone.
Patients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the recommended dose, which is defined as the dose preceding the MTD.
Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| cisplatin | Drug | – |
| cytarabine | Drug | – |
| methylprednisolone | Drug | – |
| pixantrone dimaleate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2009.
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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.
Luis Fayad, MD study chair
M.D. Anderson Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cisplatin, cytarabine and methylprednisolone in people with Lymphoma, run by Theradex at 7 sites 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: status not confirmed, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
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 7 Jul 2009.