LymphomaPhase 2NCT00006373
Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma
A Phase 2 study testing etoposide, ifosfamide and topotecan hydrochloride in people with Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute 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. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- etoposide, ifosfamide and topotecan hydrochloride
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Dec 2011
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed non-Hodgkin's lymphoma
- No lymphoblastic lymphoma
- Under 55 years of age:
- Intermediate and high grade or aggressive disease that has relapsed and/or failed at least 2 salvage chemotherapy regimens OR
- Failed to achieve complete response after first line induction chemotherapy and failed at least 1 salvage chemotherapy regimen
- Low grade or indolent disease that has relapsed or failed to achieve complete response after first line induction chemotherapy and failed more than 2 salvage chemotherapy regimens
- 55 years of age and over:
- Intermediate and high grade or aggressive disease that has relapsed and/or failed to achieve complete response after first line induction chemotherapy
- Low grade or indolent disease that has relapsed or failed to achieve complete response after first line induction chemotherapy OR
- Histologically confirmed Hodgkin's lymphoma
- Under 55 years of age:
- Received at least 2 prior salvage chemotherapy regimens
- 55 years of age and over:
- Stage III or IV disease that has relapsed or failed to achieve remission after combination induction chemotherapy
- Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence in radiation field, B symptoms, or liver or bone marrow involvement)
- No active leptomeningeal involvement or severe symptomatic CNS disease
- Prior CSF tumor involvement allowed if asymptomatic and no evidence of disease on lumbar puncture or no tumor involvement on MRI of the brain
- Solid tumors and brain metastases allowed
- No evidence of disease by MRI and physical exam following optimal prior surgery and/or radiotherapy AND
- At least 3 months since prior radiotherapy NOTE: 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 to 64
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Bilirubin no greater than 2.0 mg/dL*
- SGOT or SGPT no greater than 2.5 times normal*
- No severe hepatic dysfunction NOTE: *Unless due to primary malignancy
Renal:
- Creatinine no greater than 2.0 mg/dL OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No severe cardiac dysfunction
- Ejection fraction at least 50% by MUGA scan
- Essential hypertension controlled by medication allowed
Pulmonary:
- DLCO at least 50% of normal OR
- No symptomatic obstructive or restrictive disease
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
- No active infection
- HIV negative
- No insulin dependent diabetes mellitus
- No uncompensated major thyroid or adrenal dysfunction
- No significant skin breakdown from tumor or other disease
- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
- Prior doxorubicin or daunorubicin allowed if total dose no greater than 450 mg/m2
- No prior topotecan
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
Other:
- No concurrent nitroglycerin preparations for angina pectoris
- No concurrent antiarrhythmic drugs for major ventricular arrhythmias
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
About this study
Official title: A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (Vepesid)(TIME) Followed by Autologous Stem Cell Rescue in High Risk Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of intensive high dose chemotherapy consisting of topotecan, ifosfamide, and etoposide followed by autologous bone marrow or peripheral blood stem cell transplantation in terms of response rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's lymphoma.
- Determine the pharmacokinetic profile of high dose topotecan and etoposide in these patients.
- Determine the pharmacodynamics and toxicity of this regimen in these patients.
- Determine the role of either an up or down regulation of DNA topoisomerase I or II amount and/or activity in terms of clinical response and toxicity in patients treated with this regimen.
OUTLINE: Patients receive intensive high dose chemotherapy consisting of ifosfamide IV over 2 hours followed by topotecan IV over 30 minutes on days -8 to -6 and etoposide IV continuously over 24 hours on days -5 to -3. Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0.
Patients are followed at 3, 6, and 12 months, annually until disease relapse, and then every 6 months until death.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
- Conditions
- Lymphoma
- Being tested
- etoposide, ifosfamide, topotecan hydrochloride, autologous bone marrow transplantation, Mesna
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, 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, Hodgkin Disease, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic, Burkitt Lymphoma, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etoposideDrug
Also called vepesid(R), VP-16
Etoposide IV 500 mg/m2/day over 24 hours Days -5, -4, -3
ifosfamideDrug
Also called Ifex(R)
Ifosfamide 3,333 mg/m2/day IV over 2 hours (total dose 10,000 mg/m2)Days -8, -7, -6
topotecan hydrochlorideDrug
Also called topotecan
Topotecan 21.3 mg/m2/day (total dose 64 mg/m2 ) IV over 30 minutes Days -8, -7, -6
autologous bone marrow transplantationProcedure or surgery
MesnaDrug
Also called Mesnex(R)
Mesna 1,111 mg/m2/dose IV over 30 minutes; 30 minutes before and 4 and 8 hours after ifosfamide (total dose 10,000 mg/m2) Days -8, -7, -6
| Study group | Role | What they receive |
|---|---|---|
| TIME | Experimental | Topotecan, Ifosfamide, Mesna and Etoposide Receives: Drug: etoposide; Drug: ifosfamide; Drug: topotecan hydrochloride; Procedure: autologous bone marrow transplantation; Drug: Mesna |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival as defined as the time from date of enrollment to the time of recurrence
Measured: 3 years
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 startFeb 2000
- Primary completionOct 2006
- Study completionDec 2011
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Steven C. Goldstein, MD, Study chair, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006373
- Sponsor's protocol ID
- MCC-12246
- Other IDs
- MCC-12246, MCC-IRB-5670, SB-MCC-12246, NCI-G00-1865
- Status last verified
- Jun 2013
- First submitted
- 4 Oct 2000
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Intensive-Dose Topotecan, Ifosfamide/Mesna and Etoposide (Vepesid)(TIME) Followed by Autologous Stem Cell Rescue in High Risk Lymphoma
- ClinicalTrials.gov ID
- NCT00006373
- Acronym / sponsor ID
- MCC-12246
- Conditions
- Lymphoma
- Keywords
- stage III adult Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, recurrent adult Hodgkin lymphoma, 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2011 (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. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.
Detailed description
OBJECTIVES:
- Determine the efficacy of intensive high dose chemotherapy consisting of topotecan, ifosfamide, and etoposide followed by autologous bone marrow or peripheral blood stem cell transplantation in terms of response rate, progression free survival, and overall survival in patients with high risk non-Hodgkin's lymphoma or Hodgkin's lymphoma.
- Determine the pharmacokinetic profile of high dose topotecan and etoposide in these patients.
- Determine the pharmacodynamics and toxicity of this regimen in these patients.
- Determine the role of either an up or down regulation of DNA topoisomerase I or II amount and/or activity in terms of clinical response and toxicity in patients treated with this regimen.
OUTLINE: Patients receive intensive high dose chemotherapy consisting of ifosfamide IV over 2 hours followed by topotecan IV over 30 minutes on days -8 to -6 and etoposide IV continuously over 24 hours on days -5 to -3. Patients undergo autologous bone marrow or peripheral blood stem cell transplantation on day 0.
Patients are followed at 3, 6, and 12 months, annually until disease relapse, and then every 6 months until death.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIME | Experimental | Drug: etoposide, Drug: ifosfamide, Drug: topotecan hydrochloride, Procedure: autologous bone marrow transplantation, Drug: MesnaTopotecan, Ifosfamide, Mesna and Etoposide |
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 |
|---|---|---|
| etoposideAlso: vepesid(R), VP-16Etoposide IV 500 mg/m2/day over 24 hours Days -5, -4, -3 | Drug | TIME |
| ifosfamideAlso: Ifex(R)Ifosfamide 3,333 mg/m2/day IV over 2 hours (total dose 10,000 mg/m2)Days -8, -7, -6 | Drug | TIME |
| topotecan hydrochlorideAlso: topotecanTopotecan 21.3 mg/m2/day (total dose 64 mg/m2 ) IV over 30 minutes Days -8, -7, -6 | Drug | TIME |
| autologous bone marrow transplantation | Procedure or surgery | TIME |
| MesnaAlso: Mesnex(R)Mesna 1,111 mg/m2/dose IV over 30 minutes; 30 minutes before and 4 and 8 hours after ifosfamide (total dose 10,000 mg/m2) Days -8, -7, -6 | Drug | TIME |
Primary outcome
Progression-free survival
Time frame: 3 years
Progression-free survival as defined as the time from date of enrollment to the time of recurrence
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 4 Jun 2013.
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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.
Steven C. Goldstein, MD study chair
H. Lee Moffitt Cancer Center and Research Institute
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 etoposide, ifosfamide and topotecan hydrochloride in people with Lymphoma, run by H. Lee Moffitt Cancer Center and Research Institute 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 4 Jun 2013. 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.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). 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 4 Jun 2013.