Hodgkin DiseasePhase 2NCT00225173
Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease
A Phase 2 study testing Doxorubicin, Vinblastine and Cyclophosphamide in people with Hodgkin Disease, run by Stanford University at 1 site in United States.
Trial summary
Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine and vinorelbine. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hodgkin Disease
- What is being tested?
- Doxorubicin, Vinblastine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Sep 2006
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Untreated, locally extensive or advanced stage classical Hodgkin's disease
- 3 or more adverse risk factors
- Age > 18 years and < 70 years.
- No prior invasive malignancies for > 5 years except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- ECOG performance status 0 to 2
- WBC > 4000/µL
Show all 9Show fewer
- Platelets > 100,000/µL
- Creatinine < 2.0mg/dL
- Bilirubin < 5.0mg/dL
Who cannot join
- HIV-positive
- Pregnant or currently breast feeding women
- Lymphocyte predominant Hodgkin's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study
Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine and vinorelbine. The introduction of these new agents with their different mechanisms of action into the Stanford V regimen may increase effectiveness while maintaining a favorable toxicity profile with respect to fertility and a low risk of secondary leukemia. On this basis, we propose a new regimen, Stanford VI, for patients with bulky and advanced HD with 3 or more risk factors.
Read the detailed description
Patients will receive chemotherapy weekly for 19 weeks, alone or followed by irradiation as indicated per protocol guidelines.
- Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
- Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
- Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
- Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
- Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
- Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
- Gemcitabine 1250 mg/m2 IV w 13,15,17,19
- Vinorelbine 25 mg/m2 IV w 13,15,17,19
- Prednisone 40 mg/m2 PO qod w 1-10, taper
- Conditions
- Hodgkin Disease
- Being tested
- Doxorubicin, Vinblastine, Cyclophosphamide, Etoposide, Vincristine
- Keywords
- nodular sclerosis, lymphocyte rich, lymphocyte depleted, mixed cellularity
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxorubicinDrug
Also called Adriamycin, hydroxydaunorubicin, hydroxydaunomycin
Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
VinblastineDrug
Also called Alkaban-AQ, Velban, Vinblastine sulfate, Vincaleukoblastine
Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
CyclophosphamideDrug
Also called Cytoxan, Endoxan, Neosar, Procytox
Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
EtoposideDrug
Also called Etopophos, Toposar, VePesid, etoposide phosphate
Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
VincristineDrug
Also called Oncovin, leurocristine, VCR
Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
BleomycinDrug
Also called Blenoxane, bleomycin sulfate
Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
GemcitabineDrug
Also called Gemzar, Gemcitabine HCl
Gemcitabine 1250 mg/m2 IV w 13,15,17,19
VinorelbineDrug
Also called Navelbine, Vinorelbine tartrate
Vinorelbine 25 mg/m2 IV w 13,15,17,19
PrednisoneDrug
Also called Deltasone, Liquid Pred
Prednisone 40 mg/m2 PO qod w 1-10, taper
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | * Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
* Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
* Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
* Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
* Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
* Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
* Gemcitabine 1250 mg/m2 IV w 13,15,17,19
* Vinorelbine 25 mg/m2 IV w 13,15,17,19
* Prednisone 40 mg/m2 PO qod w 1-10, taper Receives: Drug: Doxorubicin; Drug: Vinblastine; Drug: Cyclophosphamide; Drug: Etoposide; Drug: Vincristine; Drug: Bleomycin; Drug: Gemcitabine; Drug: Vinorelbine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startOct 2001
- Primary completionSep 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sandra J. Horning, MD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225173
- Sponsor's protocol ID
- G6HD
- Other IDs
- NIH/CA56060
- Status last verified
- Sep 2005
- First submitted
- 21 Sep 2005
- Last updated
- 27 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study
- ClinicalTrials.gov ID
- NCT00225173
- Acronym / sponsor ID
- G6HD
- Conditions
- Hodgkin Disease
- Keywords
- nodular sclerosis, lymphocyte rich, lymphocyte depleted, mixed cellularity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2001
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Sep 2005 (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.
Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine and vinorelbine. The introduction of these new agents with their different mechanisms of action into the Stanford V regimen may increase effectiveness while maintaining a favorable toxicity profile with respect to fertility and a low risk of secondary leukemia. On this basis, we propose a new regimen, Stanford VI, for patients with bulky and advanced HD with 3 or more risk factors.
Detailed description
Patients will receive chemotherapy weekly for 19 weeks, alone or followed by irradiation as indicated per protocol guidelines.
- Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
- Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
- Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
- Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
- Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
- Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
- Gemcitabine 1250 mg/m2 IV w 13,15,17,19
- Vinorelbine 25 mg/m2 IV w 13,15,17,19
- Prednisone 40 mg/m2 PO qod w 1-10, taper
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Doxorubicin, Drug: Vinblastine, Drug: Cyclophosphamide, Drug: Etoposide, Drug: Vincristine, Drug: Bleomycin, Drug: Gemcitabine, Drug: Vinorelbine, Drug: Prednisone* Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11 * Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11 * Cyclophosphamide 750 mg/m2 IV w 1, 5, 9 * Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11 * Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg) * Bleomycin 5 u/m2 IV w 2,4,6,8,10,12 * Gemcitabine 1250 mg/m2 IV w 13,15,17,19 * Vinorelbine 25 mg/m2 IV w 13,15,17,19 * Prednisone 40 mg/m2 PO qod w 1-10, taper |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Untreated, locally extensive or advanced stage classical Hodgkin's disease
- 3 or more adverse risk factors
- Age > 18 years and < 70 years.
- No prior invasive malignancies for > 5 years except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- ECOG performance status 0 to 2
Key exclusion criteria (3 listed)
- HIV-positive
- Pregnant or currently breast feeding women
- Lymphocyte predominant Hodgkin's disease
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 |
|---|---|---|
| DoxorubicinAlso: Adriamycin, hydroxydaunorubicin, hydroxydaunomycinDoxorubicin 25 mg/m2 IV w 1,3,5,7,9,11 | Drug | Treatment |
| VinblastineAlso: Alkaban-AQ, Velban, Vinblastine sulfate, VincaleukoblastineVinblastine 6 mg/m2 IV w 1,3,5,7,9,11 | Drug | Treatment |
| CyclophosphamideAlso: Cytoxan, Endoxan, Neosar, ProcytoxCyclophosphamide 750 mg/m2 IV w 1, 5, 9 | Drug | Treatment |
| EtoposideAlso: Etopophos, Toposar, VePesid, etoposide phosphateEtoposide2 60 mg/mg2 x 2 IV w 3, 7,11 | Drug | Treatment |
| VincristineAlso: Oncovin, leurocristine, VCRVincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg) | Drug | Treatment |
| BleomycinAlso: Blenoxane, bleomycin sulfateBleomycin 5 u/m2 IV w 2,4,6,8,10,12 | Drug | Treatment |
| GemcitabineAlso: Gemzar, Gemcitabine HClGemcitabine 1250 mg/m2 IV w 13,15,17,19 | Drug | Treatment |
| VinorelbineAlso: Navelbine, Vinorelbine tartrateVinorelbine 25 mg/m2 IV w 13,15,17,19 | Drug | Treatment |
| PrednisoneAlso: Deltasone, Liquid PredPrednisone 40 mg/m2 PO qod w 1-10, taper | Drug | Treatment |
Primary outcome
Freedom from progression
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
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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.
Sandra J. Horning, MD study chair
Stanford University
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 Doxorubicin, Vinblastine and Cyclophosphamide in people with Hodgkin Disease, run by Stanford University 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 9 inclusion and 3 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: stopped early, as of the sponsor's last update on 27 Aug 2014. 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 was stopped early. Results are not available in the source record.
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?
Freedom from progression. 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 27 Aug 2014.