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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT00225173
Phase
PHASE2
Status
Terminated

Conditions

  • Hodgkin Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Doxorubicin — DRUG
    Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine — DRUG
    Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide — DRUG
    Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide — DRUG
    Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine — DRUG
    Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin — DRUG
    Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine — DRUG
    Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine — DRUG
    Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone — DRUG
    Prednisone 40 mg/m2 PO qod w 1-10, taper

Study Details

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.

Key Dates

Start date
Oct 31, 2001
Status verified
Sep 2005
Primary completion
Sep 30, 2005
Completion
Sep 30, 2006

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Freedom from progression

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University Medical CenterStanfordCalifornia94305-

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Stanford University Medical Center· Stanford, CA

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