Angioimmunoblastic T-cell LymphomaPhase 1NCT00101205
Oxaliplatin, Ifosfamide and Etoposide in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
A Phase 1 study testing oxaliplatin and etoposide in people with Angioimmunoblastic T-cell Lymphoma and B-cell Childhood Acute Lymphoblastic Leukemia, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Angioimmunoblastic T-cell Lymphoma, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia
- What is being tested?
- oxaliplatin and etoposide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Jan 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Life expectancy > 8 weeks
- Albumin > 2 g/dL
- Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic verification not required for brainstem tumors or optic pathway tumors; lymphoma; recurrent or refractory to conventional therapy OR no known effective therapy exists; bone marrow involvement allowed
- Performance Status: Karnofsky >= 50 % (patients > 10 years of age) OR Lansky >= 50% (patients for =< 10 years of age)
- Absolute neutrophil count > 1,000/mm^3
- Platelet count > 100,000/mm^3 (transfusion independent)
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- Hemoglobin > 8 g/dL (transfusion allowed)
- ALT < 5.0 times ULN
- Creatinine normal OR glomerular filtration rate >= 80 mL/min/1.73 m^2
- Calcium normal (electrolyte supplements allowed)
- Echocardiogram and EKG normal
- Shortening fraction >= 27% OR ejection fraction > 50%
- No evidence of dyspnea at rest
- No exercise intolerance
- Pulse oximetry > 94% on room air
- Neurologic deficits due to CNS tumor must be relatively stable for >= 2 weeks before study entry
- Seizure disorder allowed provided well-controlled by non-enzyme-inducing anticonvulsants
- No peripheral neurotoxicity > grade 1
- Sodium, potassium, and magnesium normal (electrolyte supplements allowed)
- At least 1 week since prior biologic agents
- More than 1 week since prior growth factors
- More than 6 months since prior allogeneic peripheral blood stem cell transplantation AND no active graft-versus-host disease
- More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
- More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites
- More than 6 weeks since prior substantial bone marrow radiotherapy
- More than 3 months since prior craniospinal (> 24 Gy), whole pelvis, or total-body radiotherapy
- Recovered from all prior therapy
- No concurrent enzyme-inducing anticonvulsants, including, but not limited to, the following: Barbiturates; Phenytoin; Carbamazepine
Who cannot join
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No history of life-threatening hypersensitivity to platinum-containing agents
- No prior oxaliplatin
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- No other concurrent investigational agents
- No other concurrent anticancer therapy
- Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas
This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may also help etoposide work better by making cancer cells more sensitive to the drug. Giving oxaliplatin together with etoposide may kill more cancer cells.
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose of oxaliplatin and etoposide in pediatric patients with recurrent or refractory solid tumors or lymphoma.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
SECONDARY OBJECTIVES:
- Determine the pharmacokinetic profile of this regimen in these patients. II. Correlate the extent of oxaliplatin and etoposide exposure with toxic effects and therapeutic effects of this regimen in these patients.
III. Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and etoposide 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.
- Conditions
- Angioimmunoblastic T-cell Lymphoma, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis
- Being tested
- oxaliplatin, etoposide
- Medical subject headings
- Immunoblastic Lymphadenopathy, Leukemia, Lymphocytic, Chronic, B-Cell, Burkitt Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Extranodal NK-T-Cell, Intraocular Lymphoma, Lymphoma, T-Cell, Peripheral, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxaliplatinDrug
Also called 1-OHP, Dacotin, Dacplat, Eloxatin
Given IV
etoposideDrug
Also called EPEG, VP-16, VP-16-213
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: oxaliplatin; Drug: etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Measured: 21 days
MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2005 (estimated)
- Study startNov 2004
- Primary completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angioimmunoblastic T-cell 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa McGregor, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101205
- Sponsor's protocol ID
- NCI-2009-00075
- Other IDs
- NCI-2009-00075, CDR0000405828, OXALET, 6634, P30CA021765
- Status last verified
- Apr 2013
- First submitted
- 7 Jan 2005
- Last updated
- 24 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of the Combination of Oxaliplatin (NSC 266046, IND 57004), Ifosfamide, and Etoposide in Recurrent or Refractory Pediatric Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT00101205
- Acronym / sponsor ID
- NCI-2009-00075
- Conditions
- Angioimmunoblastic T-cell Lymphoma, B-cell Childhood Acute Lymphoblastic Leukemia, B-cell Chronic Lymphocytic Leukemia, Childhood Burkitt Lymphoma, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Nov 2004
- Primary completion
- Jan 2012 (actual)
- First posted
- 10 Jan 2005 (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.
This phase I trial is studying the side effects and best dose of oxaliplatin and etoposide in treating young patients with recurrent or refractory solid tumors or lymphomas. Drugs used in chemotherapy, such as oxaliplatin and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Oxaliplatin may also help etoposide work better by making cancer cells more sensitive to the drug. Giving oxaliplatin together with etoposide may kill more cancer cells.
Detailed description
PRIMARY OBJECTIVES:
- Determine the maximum tolerated dose of oxaliplatin and etoposide in pediatric patients with recurrent or refractory solid tumors or lymphoma.
II. Determine the dose-limiting toxic effects of this regimen in these patients.
SECONDARY OBJECTIVES:
- Determine the pharmacokinetic profile of this regimen in these patients. II. Correlate the extent of oxaliplatin and etoposide exposure with toxic effects and therapeutic effects of this regimen in these patients.
III. Determine, preliminarily, the antitumor activity of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and etoposide 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: oxaliplatin, Drug: etoposidePatients receive oxaliplatin IV over 2 hours on day 1 and etoposide IV over 1 hour on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (28 listed)
- Life expectancy > 8 weeks
- Albumin > 2 g/dL
- Histologically confirmed diagnosis of 1 of the following: solid tumor; histologic verification not required for brainstem tumors or optic pathway tumors; lymphoma; recurrent or refractory to conventional therapy OR no known effective therapy exists; bone marrow involvement allowed
- Performance Status: Karnofsky >= 50 % (patients > 10 years of age) OR Lansky >= 50% (patients for =< 10 years of age)
- Absolute neutrophil count > 1,000/mm^3
Key exclusion criteria (9 listed)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled infection
- No history of life-threatening hypersensitivity to platinum-containing agents
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 |
|---|---|---|
| oxaliplatinAlso: 1-OHP, Dacotin, Dacplat, EloxatinGiven IV | Drug | Arm I |
| etoposideAlso: EPEG, VP-16, VP-16-213Given IV | Drug | Arm I |
Primary outcome
MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
Time frame: 21 days
MTD of the addition of ifosfamide to the combination of oxaliplatin and etoposide assessed by CTCAE version 3.0
Time frame: 21 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
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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.
Lisa McGregor principal investigator
St. Jude Children's Research Hospital
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 oxaliplatin and etoposide in people with Angioimmunoblastic T-cell Lymphoma and B-cell Childhood Acute Lymphoblastic Leukemia, 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 28 inclusion and 9 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: stopped early, as of the sponsor's last update on 24 Feb 2014. 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 was stopped early. 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.
What does the primary outcome measure?
MTD of the combination of oxaliplatin and etoposide assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (time frame: 21 days). The study lists 2 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 24 Feb 2014.