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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2006-09-30

Brief Summary

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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.

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Detailed Description

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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

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Hodgkin Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

* 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

Group Type EXPERIMENTAL

Doxorubicin

Intervention Type DRUG

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

Vinblastine

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Etoposide

Intervention Type DRUG

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

Vincristine

Intervention Type DRUG

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

Bleomycin

Intervention Type DRUG

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

Gemcitabine

Intervention Type DRUG

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

Vinorelbine

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

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

Interventions

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Doxorubicin

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

Intervention Type DRUG

Vinblastine

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Etoposide

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

Intervention Type DRUG

Vincristine

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

Intervention Type DRUG

Bleomycin

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

Intervention Type DRUG

Gemcitabine

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

Intervention Type DRUG

Vinorelbine

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

Intervention Type DRUG

Prednisone

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

Intervention Type DRUG

Other Intervention Names

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Adriamycin hydroxydaunorubicin hydroxydaunomycin Alkaban-AQ Velban Vinblastine sulfate Vincaleukoblastine VLB Cytoxan Endoxan Neosar Procytox Revimmune cytophosphane Etopophos Toposar VePesid etoposide phosphate VP-16 Oncovin leurocristine VCR Blenoxane bleomycin sulfate Gemzar Gemcitabine HCl Navelbine Vinorelbine tartrate Deltasone Liquid Pred

Eligibility Criteria

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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