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

NCT00225173 | Terminated Phase 2

• 2 other identifiers: G6HDNIH/CA56060
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Disease

Keywords

nodular sclerosis; lymphocyte rich; lymphocyte depleted; mixed cellularity

Outcome Measures

Primary Outcomes (1)

• Freedom from progression

Study Arms (1)

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

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

Interventions

Doxorubicin DRUG

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

Also known as: Adriamycin, hydroxydaunorubicin, hydroxydaunomycin

Treatment

Vinblastine DRUG

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

Also known as: Alkaban-AQ, Velban, Vinblastine sulfate, Vincaleukoblastine, VLB

Treatment

Cyclophosphamide DRUG

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

Also known as: Cytoxan, Endoxan, Neosar, Procytox, Revimmune, cytophosphane

Treatment

Etoposide DRUG

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

Also known as: Etopophos, Toposar, VePesid, etoposide phosphate, VP-16

Treatment

Vincristine DRUG

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

Also known as: Oncovin, leurocristine, VCR

Treatment

Bleomycin DRUG

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

Also known as: Blenoxane, bleomycin sulfate

Treatment

Gemcitabine DRUG

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

Also known as: Gemzar, Gemcitabine HCl

Treatment

Vinorelbine DRUG

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

Also known as: Navelbine, Vinorelbine tartrate

Treatment

Prednisone DRUG

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

Also known as: Deltasone, Liquid Pred

Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated, locally extensive or advanced stage classical Hodgkin's disease
• 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

You may not qualify if:

• HIV-positive
• Pregnant or currently breast feeding women
• Lymphocyte predominant Hodgkin's disease

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Doxorubicin; Vinblastine; Cyclophosphamide; Etoposide; etoposide phosphate; Vincristine; Bleomycin; Gemcitabine; Vinorelbine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Glycopeptides; Glycoconjugates; Peptides; Amino Acids, Peptides, and Proteins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Sandra J. Horning, MD

  Stanford University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2005
• First Posted: September 23, 2005
• Study Start: October 1, 2001
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2006
• Last Updated: August 27, 2014

Record last verified: 2005-09

Locations

US (1)