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Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00026208
First received: November 9, 2001
Last updated: August 2, 2013
Last verified: August 2013

November 9, 2001
August 2, 2013
June 2001
May 2015   (final data collection date for primary outcome measure)
Progression-free survival by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00026208 on ClinicalTrials.gov Archive Site
  • Early and late treatment-related toxicity [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
  • Freedom from second disease progression by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ] [ Designated as safety issue: No ]
  • Overall survival by Kaplan-Meier [ Time Frame: at 5 and 10 years ] [ Designated as safety issue: No ]
  • Frequency of complete response by positron-emission tomography scan [ Time Frame: between weeks 4 and 5 of chemotherapy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Combination Chemotherapy Plus Low-Dose Radiation Therapy in Treating Patients With Stage I or Stage IIA Hodgkin's Lymphoma
Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study

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.

OBJECTIVES:

  • Evaluate the freedom from progression in patients with stage I or IIA Hodgkin's lymphoma with a favorable prognosis treated with Stanford V-C chemotherapy comprising cyclophosphamide, doxorubicin, vinblastine, prednisone, vincristine, bleomycin, and etoposide with low-dose radiotherapy.
  • Minimize the early and late effects of treatment in these patients by avoiding staging laparotomy and its consequences, limiting cumulative doses of chemotherapy, and reducing the dose of radiotherapy to moderately bulky sites of disease.
  • Assess early and late treatment-related toxicity, freedom from second disease progression, and overall survival at 5 and 10 years in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive Stanford V-C chemotherapy comprising cyclophosphamide IV over 30-60 minutes weekly on weeks 1 and 5; doxorubicin IV and vinblastine IV over 5 minutes once weekly on weeks 1, 3, 5, and 7; oral prednisone every other day on weeks 1-8; vincristine IV and bleomycin IV over 5 minutes once weekly on weeks 2, 4, 6, and 8; and etoposide IV over 60 minutes on days 1 and 2 of weeks 3 and 7. Beginning 2-3 weeks after completion of chemotherapy, patients undergo low-dose radiotherapy 5 days a week for approximately 3 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study within 5 years.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma, Hodgkin Disease
  • Lymphoma
  • Hodgkin Disease
  • Lymphoma: Hodgkin
  • Drug: bleomycin
    5 u/m2 IV week 2, 4, 6, 8
  • Drug: cyclophosphamide
    650 mg/m2
  • Drug: prednisone
    40 mg/m2, Oral. Every other day. Taper 10 mg qod during last 2 weeks of chemotherapy
  • Drug: vincristine
    1.4 mg/m2; IV wk 2, 4, 6, 8
  • Drug: Adriamycin
    25 mg/m2
  • Drug: Velban
    6 mg/m2, IV wk 1, 3, 5, 7
  • Drug: VP-16
    60 mg/m2 x 2; IV wk 3, 7 (d 15, 16, 43, 44)
Experimental: chemotherapy + Stanford V-C
Interventions:
  • Drug: bleomycin
  • Drug: cyclophosphamide
  • Drug: prednisone
  • Drug: vincristine
  • Drug: Adriamycin
  • Drug: Velban
  • Drug: VP-16
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:DISEASE CHARACTERISTICS:

  • Diagnosis of stage I or IIA Hodgkin's lymphoma

    • Previously untreated disease
    • Eligible subtypes:

      1. Nodular sclerosis
      2. Mixed cellularity
      3. 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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00026208
LYMHD0002
Not Provided
Stanford University
Stanford University
Not Provided
Principal Investigator: Louis Fehrenbacher Kaiser Permanente Medical Center
Stanford University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP