PediatricPhase 2NCT00592111
A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)
A Phase 2 study testing COPP/ABV and intensive chemo with concurrent growth factor in people with Pediatric and Hodgkin's Disease, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Pediatric, Hodgkin's Disease
- What is being tested?
- COPP/ABV and intensive chemo with concurrent growth factor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1996to Jan 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
- Age less than 21 years at diagnosis
- Previously untreated, pathologically confirmed diagnosis of Hodgkin's disease.
- Informed patient/parental consent as required by individual institution and in accordance with the Dept of Health and Human Services
- Approval of this protocol by the individual institutional Human Subjects Review Committee.
- Indicate Hodgkin's disease clinical stage.
- Indicate presence or absence of "B" symptoms.
- For Stage I and II disease indicate the following:
- presence or absence of bulk disease
- number of involved nodal regions
- presence or absence of hilar adenopathy
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.
- Conditions
- Pediatric, Hodgkin's Disease
- Being tested
- COPP/ABV, intensive chemo with concurrent growth factor
- Keywords
- Pediatric, Hodgkin's Disease, 96-016
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPP/ABVDrug
Also called Cyclophosphamide, Vincristine, Procarbazine, Prednisone
4 courses of COPP/ABV hybrid
COPP/ABVDrug
Also called Cyclophosphamide, Vincristine, Procarbazine, Prednisone
6 courses of COPP/ABV hybrid
intensive chemo with concurrent growth factorDrug
Also called Cyclophosphamide, Vincristine, Procarbazine, Prednisone
6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: COPP/ABV |
| 2 | Experimental | Not described Receives: Drug: COPP/ABV |
| 3 | Experimental | Not described Receives: Drug: intensive chemo with concurrent growth factor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy
Measured: Conclusion of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startMar 1996
- Primary completionFeb 1999
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PediatricStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Cancer Group
- Responsible party
- Sponsor
- Investigators
- Tanya Trippett, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592111
- Sponsor's protocol ID
- 96-016
- Other IDs
- CCG 5942, CA42764
- Status last verified
- Dec 2015
- First submitted
- 26 Dec 2007
- Last updated
- 23 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Study of Clinically Staged Pediatric Hodgkin's Disease: Chemotherapy for All Patients; Supplementary Low Dose Involved Field Irradiation for Selected Patients (CCG 5942)
- ClinicalTrials.gov ID
- NCT00592111
- Acronym / sponsor ID
- 96-016
- Conditions
- Pediatric, Hodgkin's Disease
- Keywords
- Pediatric, Hodgkin's Disease, 96-016
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Children's Cancer Group
- Study start
- Mar 1996
- Primary completion
- Feb 1999 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Jan 2008 (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.
Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: COPP/ABV |
| 2 | Experimental | Drug: COPP/ABV |
| 3 | Experimental | Drug: intensive chemo with concurrent growth factor |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| COPP/ABVAlso: Cyclophosphamide, Vincristine, Procarbazine, Prednisone4 courses of COPP/ABV hybrid | Drug | 1 |
| COPP/ABVAlso: Cyclophosphamide, Vincristine, Procarbazine, Prednisone6 courses of COPP/ABV hybrid | Drug | 2 |
| intensive chemo with concurrent growth factorAlso: Cyclophosphamide, Vincristine, Procarbazine, Prednisone6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor | Drug | 3 |
Primary outcome
Determine the role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy
Time frame: Conclusion of the study
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 23 Dec 2015.
- Related InfoLink provided by the sponsor.
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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.
Tanya Trippett, MD principal investigator
Memorial Sloan Kettering 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 COPP/ABV and intensive chemo with concurrent growth factor in people with Pediatric and Hodgkin's Disease, run by Memorial Sloan Kettering Cancer Center 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 23 Dec 2015. 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 role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy (time frame: Conclusion of the study). 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 23 Dec 2015.