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

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Hodgkin Disease

Treatments: Drug: Vincristine; Drug: Vinblastine; Drug: Prednisone; Drug: Vinorelbine; Drug: Etoposide; Drug: Bleomycin; Drug: Cyclophosphamide; Drug: Gemcitabine; Drug: Doxorubicin

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00225173

G6HD

NIH/CA56060

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Treatment

Experimental group

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

Treatment:

Drug: Doxorubicin

Drug: Gemcitabine

Drug: Cyclophosphamide

Drug: Bleomycin

Drug: Vinorelbine

Drug: Etoposide

Drug: Prednisone

Drug: Vincristine

Drug: Vinblastine