Sandra Horning
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with low-dose radiation therapy works in treating patients with stage I or stage IIA Hodgkin's lymphoma.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: bleomycin
- Drug: cyclophosphamide
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: prednisone
- Drug: vinblastine
- Drug: vincristine
- Procedure: chemotherapy
- Procedure: radiation therapy
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 70 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Diagnosis of stage I or IIA Hodgkin's lymphoma
o Previously untreated disease
o Eligible subtypes:
a. Nodular sclerosis
b. Mixed cellularity
c. Classical, not otherwise specified
- No lymphocyte-predominant Hodgkin's lymphoma
- No mediastinal mass that is one-third or more of the maximum intrathoracic diameter on a standing posterior chest x-ray
- No lymph node mass more than 10 cm in greatest transaxial diameter
- No more than 1 extranodal site of disease
- No constitutional (B) symptoms present at diagnosis
PATIENT CHARACTERISTICS:
Age:
- 18 to 70
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 2,000/mm^3
- Platelet count at least 150,000/mm^3
Hepatic:
- Bilirubin no greater than 2.5 mg/dL
Renal:
- Creatinine no greater than 2 mg/dL
Cardiovascular:
- Ejection fraction at least 50% for patients over age 50 or with a history of cardiac disease
Other:
- HIV negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other prior or concurrent malignancy within the past 5 years except basal cell skin cancer
- No other medical contraindication to study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic therapy
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- No prior endocrine therapy
Radiotherapy:
- No prior radiotherapy
Surgery:
- Not specified
Other:
- No other concurrent investigational drugs
- No other concurrent antineoplastic therapy
Key Exclusion Criteria:
Additional Study Details
Official Title:
Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 StudyAnticipated start date:
6/12/2001Lead Sponsor:
NCIInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Progression-free survival by Kaplan-Meier at completion of therapy and then annually for 3 years
Secondary Outcomes:
- Early and late treatment-related toxicity
- Freedom from second disease progression by Kaplan-Meier
- Overall survival by Kaplan-Meier at 5 and 10 years
- Frequency of complete response by positron-emission tomography scan between weeks 4 and 5 of chemotherapy
Total Number to be Enrolled:
80Total Number to be Enrolled at Stanford:
50More Information
Secondary ID(s):
- 77195
- CA56060
- LYMHD0002
- NCI-V01-1671
- NCT00026208
- SUMC-G5
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
9/23/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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