LymphomaPhase 2NCT00007865
Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
A Phase 2 study testing rituximab, carboplatin and etoposide in people with Lymphoma, run by University of Nebraska at 1 site 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. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Read more about this study
- Who is it for?
- Ages 19 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, carboplatin and etoposide
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2000to 22 Apr 2008
- 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 19 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed recurrent or refractory B-cell non-Hodgkin's lymphoma
- o CD20 positive
- Bidimensionally measurable or evaluable disease
- 19 years old and over
- ECOG 0-2 or Karnofsky 70-100%
- Life expectancy at least 3 months
Show all 14Show fewer
- WBC at least 3,000/mm3
- Granulocyte count at least 1,000/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 1.5 times upper limit of normal(ULN)
- AST or ALT no greater than 2.5 times ULN
- Creatinine no greater than 1.5 mg/dL
- Fertile patients must use effective contraception
- Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions (e.g., insulin for diabetes)
Who cannot join
- No myelodysplastic syndrome or chronic myeloid leukemia
- Not pregnant or nursing/negative pregnancy test
- No other prior malignancy except curatively treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
- No active serious infection
- No other concurrent serious medical condition that would preclude study
- No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's lymphoma
Show all 11Show fewer
- No other concurrent chemotherapy
- No concurrent corticosteroids except transient administration as antiemetic
- No concurrent radiotherapy
- No other concurrent investigational therapy
- No other concurrent antitumor agents
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, Eppley Cancer Center
Omaha, Nebraska, 68198-7680
About this study
Official title: A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the chemosensitivity rate in patients with recurrent or refractory non-Hodgkin's lymphoma treated with ifosfamide, carboplatin, and etoposide (ICE) in combination with rituximab.
- Determine whether the addition of rituximab changes the toxicity profile of the ICE chemotherapy regimen in these patients.
OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour, etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.
- Conditions
- Lymphoma
- Being tested
- rituximab, carboplatin, etoposide, ifosfamide
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
Also called Rituxan
carboplatinDrug
Also called Paraplatin
etoposideDrug
Also called Etopophos, Toposar
ifosfamideDrug
Also called Ifex
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start1 Sep 2000
- Primary completion1 Mar 2004
- Study completion22 Apr 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.
- More trials run by University of NebraskaThe 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
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julie M Vose, MD, Study chair, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007865
- Sponsor's protocol ID
- 0032-00-FB
- Other IDs
- P30CA036727, NCI-V00-1635
- Status last verified
- Dec 2023
- First submitted
- 6 Jan 2001
- Last updated
- 27 Dec 2023
- Results posted
- No
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy
- ClinicalTrials.gov ID
- NCT00007865
- Acronym / sponsor ID
- 0032-00-FB
- Conditions
- Lymphoma
- Keywords
- recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult Burkitt lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2000 (actual)
- Primary completion
- 1 Mar 2004 (actual)
- Study completion
- 22 Apr 2008 (actual)
- First posted
- 27 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. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the chemosensitivity rate in patients with recurrent or refractory non-Hodgkin's lymphoma treated with ifosfamide, carboplatin, and etoposide (ICE) in combination with rituximab.
- Determine whether the addition of rituximab changes the toxicity profile of the ICE chemotherapy regimen in these patients.
OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour, etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who are not candidates for autologous stem cell transplantation may receive 1-4 more courses of chemotherapy without rituximab.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 19 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed recurrent or refractory B-cell non-Hodgkin's lymphoma
- o CD20 positive
- Bidimensionally measurable or evaluable disease
- 19 years old and over
- ECOG 0-2 or Karnofsky 70-100%
Key exclusion criteria (11 listed)
- No myelodysplastic syndrome or chronic myeloid leukemia
- Not pregnant or nursing/negative pregnancy test
- No other prior malignancy except curatively treated basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix
- No active serious infection
- No other concurrent serious medical condition that would preclude study
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 |
|---|---|---|
| rituximabAlso: Rituxan | Biological | – |
| carboplatinAlso: Paraplatin | Drug | – |
| etoposideAlso: Etopophos, Toposar | Drug | – |
| ifosfamideAlso: Ifex | 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 27 Dec 2023.
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
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.
Julie M Vose, MD study chair
University of Nebraska
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 rituximab, carboplatin and etoposide in people with Lymphoma, run by University of Nebraska 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 11 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 27 Dec 2023. 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.
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 27 Dec 2023.