Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Doxorubicin

Vinblastine

Cyclophosphamide

Etoposide

Vincristine

Bleomycin

Gemcitabine

Vinorelbine

Prednisone

About this trial

This is an interventional treatment trial for Hodgkin Disease focused on measuring nodular sclerosis, lymphocyte rich, lymphocyte depleted, mixed cellularity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Platelets > 100,000/µL Creatinine < 2.0mg/dL Bilirubin < 5.0mg/dL Exclusion Criteria: HIV-positive Pregnant or currently breast feeding women Lymphocyte predominant Hodgkin's disease

Sites / Locations

Stanford University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Freedom from progression

Secondary Outcome Measures

Full Information

NCT ID

NCT00225173

First Posted

September 21, 2005

Last Updated

August 26, 2014

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00225173

Brief Title

Combination Chemotherapy +/- Radiation in High Risk Hodgkin's Disease

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Terminated

Study Start Date

October 2001 (undefined)

Primary Completion Date

September 2005 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin Disease

Keywords

nodular sclerosis, lymphocyte rich, lymphocyte depleted, mixed cellularity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

Adriamycin, hydroxydaunorubicin, hydroxydaunomycin

Intervention Description

Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11

Intervention Type

Drug

Intervention Name(s)

Vinblastine

Other Intervention Name(s)

Alkaban-AQ, Velban, Vinblastine sulfate, Vincaleukoblastine, VLB

Intervention Description

Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cytoxan, Endoxan, Neosar, Procytox, Revimmune, cytophosphane

Intervention Description

Cyclophosphamide 750 mg/m2 IV w 1, 5, 9

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

Etopophos, Toposar, VePesid, etoposide phosphate, VP-16

Intervention Description

Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

Oncovin, leurocristine, VCR

Intervention Description

Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)

Intervention Type

Drug

Intervention Name(s)

Bleomycin

Other Intervention Name(s)

Blenoxane, bleomycin sulfate

Intervention Description

Bleomycin 5 u/m2 IV w 2,4,6,8,10,12

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar, Gemcitabine HCl

Intervention Description

Gemcitabine 1250 mg/m2 IV w 13,15,17,19

Intervention Type

Drug

Intervention Name(s)

Vinorelbine

Other Intervention Name(s)

Navelbine, Vinorelbine tartrate

Intervention Description

Vinorelbine 25 mg/m2 IV w 13,15,17,19

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Deltasone, Liquid Pred

Intervention Description

Prednisone 40 mg/m2 PO qod w 1-10, taper

Primary Outcome Measure Information:

Title

Freedom from progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: 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 Platelets > 100,000/µL Creatinine < 2.0mg/dL Bilirubin < 5.0mg/dL Exclusion Criteria: HIV-positive Pregnant or currently breast feeding women Lymphocyte predominant Hodgkin's disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sandra J. Horning, MD

Organizational Affiliation

Stanford University

Official's Role

Study Chair

Facility Information:

Facility Name

Stanford University Medical Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Hodgkin Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial