LymphomaPhase 2NCT00003114
Combination Chemotherapy in Treating Patients With AIDS-Related Hodgkin's Disease
A Phase 2 study testing filgrastim, cyclophosphamide and etoposide in people with Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with lomustine, etoposide, cyclophosphamide, and procarbazine in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymphoma
- What is being tested?
- filgrastim, cyclophosphamide and etoposide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1997to Feb 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically proven stage IIB-IV AIDS-related Hodgkin's disease
- Patients with Hodgkin's disease as the only HIV-related condition must have a positive ELISA for HIV confirmed by Western Blot
- Measurable or evaluable disease
- No cytologic or radiologic evidence of CNS involvement
PATIENT CHARACTERISTICS:
Age:
- Any age
Performance status:
- ECOG 0-3
Life expectancy:
- At least 6 weeks
Hematopoietic:
- WBC at least 1,500/mm3
- Platelet count at least 50,000/mm3
Hepatic:
- Bilirubin no greater than 3.0 mg/dL
Renal:
- Creatinine no greater than 3.0 mg/dL
Other:
- Active infection is allowed (provided prognosis is estimated to be at least 6 weeks)
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for Hodgkin's disease
- At least 4 weeks since chemotherapy for Kaposi's sarcoma
Endocrine therapy:
- Not specified
Radiotherapy:
- Prior radiotherapy for localized stage I or II disease that has progressed beyond initial radiation ports is allowed
Surgery:
- Not specified
Other:
- Concurrent AZT therapy is allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients with stage IIB, stage III, or stage IV AIDS-related Hodgkin's disease.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease.
- Assess the feasibility and toxic effects of CECP in this patient population.
OUTLINE: Patients receive oral lomustine on day 1, oral etoposide on days 1-3, and oral cyclophosphamide and procarbazine on days 22-31. Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42. The course is repeated every 6 weeks.
Patients with a complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy. Patients failing to respond after 1 course are removed from the study.
Patients will be followed every 3 months until death.
PROJECTED ACCRUAL: A minimum of 16 evaluable patients will be accrued.
- Conditions
- Lymphoma
- Being tested
- filgrastim, cyclophosphamide, etoposide, lomustine, procarbazine hydrochloride
- Keywords
- AIDS-related lymphoma, HIV-associated Hodgkin lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, AIDS-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filgrastimBiological
Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42.The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
cyclophosphamideDrug
Oral cyclophosphamide on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
etoposideDrug
Oral etoposide on days 1-3. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
lomustineDrug
Patients receive oral lomustine on day 1.
procarbazine hydrochlorideDrug
Oral and procarbazine on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course.
radiation therapyRadiation
Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease.
Measured: The course is repeated every 6 weeks. Patients will be followed every 3 months until death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2003 (estimated)
- Study startJul 1997
- Primary completionJun 2002
- Study completionFeb 2003
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 Case Comprehensive Cancer CenterThe 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Scot C. Remick, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003114
- Sponsor's protocol ID
- CWRU2496
- Other IDs
- P30CA043703, CWRU-2496, AMC-4A-90, NCI-G97-1351
- Status last verified
- Jun 2010
- First submitted
- 1 Nov 1999
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Combination Chemotherapy in the Treatment of AIDS-Associated Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00003114
- Acronym / sponsor ID
- CWRU2496
- Conditions
- Lymphoma
- Keywords
- AIDS-related lymphoma, HIV-associated Hodgkin lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1997
- Primary completion
- Jun 2002 (actual)
- Study completion
- Feb 2003 (actual)
- First posted
- 13 Aug 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 tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients with stage IIB, stage III, or stage IV AIDS-related Hodgkin's disease.
Detailed description
OBJECTIVES:
- Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease.
- Assess the feasibility and toxic effects of CECP in this patient population.
OUTLINE: Patients receive oral lomustine on day 1, oral etoposide on days 1-3, and oral cyclophosphamide and procarbazine on days 22-31. Filgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42. The course is repeated every 6 weeks.
Patients with a complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. Patients with partial response or stable disease receive radiation therapy and/or continued chemotherapy. Patients failing to respond after 1 course are removed from the study.
Patients will be followed every 3 months until death.
PROJECTED ACCRUAL: A minimum of 16 evaluable patients will be accrued.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| filgrastimFilgrastim (granulocyte colony-stimulating factor) is given subcutaneously on days 5-21 and 33-42.The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. | Biological | – |
| cyclophosphamideOral cyclophosphamide on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. | Drug | – |
| etoposideOral etoposide on days 1-3. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. | Drug | – |
| lomustinePatients receive oral lomustine on day 1. | Drug | – |
| procarbazine hydrochlorideOral and procarbazine on days 22-31. The course is repeated every 6 weeks. A complete or partial response after 1 course of treatment receive two additional courses, but lomustine is omitted in the second course. | Drug | – |
| radiation therapyPatients with partial response or stable disease receive radiation therapy and/or continued chemotherapy. | Radiation | – |
Primary outcome
Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease.
Time frame: The course is repeated every 6 weeks. Patients will be followed every 3 months until death.
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 11 Jun 2010.
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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.
Scot C. Remick, MD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
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 filgrastim, cyclophosphamide and etoposide in people with Lymphoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2010. 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?
Determine the objective response rate, response duration, and survival of patients receiving lomustine/etoposide/cyclophosphamide/procarbazine (CECP) for stage IIB-IV AIDS-related Hodgkin's disease. (time frame: The course is repeated every 6 weeks. Patients will be followed every 3 months until death.). 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 11 Jun 2010.