LymphomaPhase 2NCT00006669
Rituximab Followed by Combination Chemotherapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
A Phase 2 study testing rituximab, sargramostim and EPOCH regimen in people with Lymphoma, run by Medstar Health Research Institute at 2 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to kill cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- rituximab, sargramostim and EPOCH regimen
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 1999to Jan 2000
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Diagnosis of intermediate grade B-cell CD20+ non-Hodgkin's lymphoma Failed to achieve initial complete response (CR) after at least 2 courses of standard chemotherapy OR Relapsed after CR and not eligible for autologous bone marrow transplant Measurable disease defined as one of the following: Bidimensionally measurable disease at least 2 cm in diameter by radiograph or CT scan Enlarged spleen extending at least 2 cm below the costal due to lymphomatous involvement Enlarged liver with focal lesions on CT scan or biopsy proven lesions Lymphomatous hepatic involvement must be biopsy proven for the liver to be sole area of measurable disease No evidence of CNS involvement A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3* Platelet count at least 100,000/mm3* *unless there is bone marrow involvement with lymphoma Hepatic: Bilirubin less than 3 mg/dL AST/ALT less than 2 times normal Renal: Creatinine less than 2.1 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 45% by MUGA or echocardiogram Other: No prior malignancy within the past 10 years except squamous cell carcinoma or basal cell carcinoma of the skin or cervical cancer No evidence of infection HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior rituximab
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Franklin Square Hospital Center
Baltimore, Maryland, 21237
Washington Cancer Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-cell Non-Hodgkin's Lymphoma
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to kill cancer cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent CD20+ intermediate grade B-cell non-Hodgkin's lymphoma treated with rituximab followed by etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH). II. Determine the toxicity of the regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive rituximab IV over 4-10 hours on day 1 followed by etoposide, vincristine, and doxorubicin IV continuously on days 4-7, cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 9 until blood counts recover. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
- Conditions
- Lymphoma
- Being tested
- rituximab, sargramostim, EPOCH regimen, cyclophosphamide, doxorubicin hydrochloride
- Keywords
- recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabBiological
sargramostimBiological
EPOCH regimenDrug
cyclophosphamideDrug
etoposideDrug
prednisoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2004 (estimated)
- Study startSep 1999
- Primary completionJan 2000
- Study completionJan 2000
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 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sein Aung, MD, Study chair, Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006669
- Sponsor's protocol ID
- CDR0000068283
- Other IDs
- WHC-99365, NCI-V00-1630
- Status last verified
- May 2001
- First submitted
- 6 Dec 2000
- Last updated
- 27 Oct 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of EPOCH and Rituxan Combined Therapy in Patients With Refractory or Relapsed CD20 Positive Intermediate Grade B-cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT00006669
- Acronym / sponsor ID
- CDR0000068283
- Conditions
- Lymphoma
- Keywords
- recurrent grade 3 follicular lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Sep 1999
- Primary completion
- Jan 2000
- Study completion
- Jan 2000
- First posted
- 4 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.
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to kill cancer cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab followed by combination chemotherapy in treating patients who have refractory or recurrent non-Hodgkin's lymphoma.
Detailed description
OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent CD20+ intermediate grade B-cell non-Hodgkin's lymphoma treated with rituximab followed by etoposide, vincristine, doxorubicin, cyclophosphamide, and prednisone (EPOCH). II. Determine the toxicity of the regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive rituximab IV over 4-10 hours on day 1 followed by etoposide, vincristine, and doxorubicin IV continuously on days 4-7, cyclophosphamide IV over 5-30 minutes on day 8 and oral prednisone on days 4-8. Patients also receive sargramostim (GM-CSF) subcutaneously beginning on day 9 until blood counts recover. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
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 |
|---|---|---|
| rituximab | Biological | – |
| sargramostim | Biological | – |
| EPOCH regimen | Drug | – |
| cyclophosphamide | Drug | – |
| doxorubicin hydrochloride | Drug | – |
| etoposide | Drug | – |
| prednisone | Drug | – |
| vincristine sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
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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.
Sein Aung, MD study chair
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
2 sites 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, sargramostim and EPOCH regimen in people with Lymphoma, run by Medstar Health Research Institute at 2 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: withdrawn, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 was withdrawn before enrolling participants, so there are no results.
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 Oct 2021.