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
  Purpose

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.


Condition Intervention Phase
Lymphoma, Hodgkin Disease
Lymphoma
Hodgkin Disease
Lymphoma: Hodgkin
Drug: bleomycin
Drug: cyclophosphamide
Drug: prednisone
Drug: vincristine
Drug: Adriamycin
Drug: Velban
Drug: VP-16
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Risk Adapted Stanford V-C With Radiotherapy for Clinical Stage I and IIA Favorable Hodgkin's Disease: The G5 Study

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Progression-free survival by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: June 2001
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy + Stanford V-C 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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026208

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Kaiser Permanente Medical Center
Vallejo, California, United States, 94589
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Louis Fehrenbacher Kaiser Permanente Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00026208     History of Changes
Other Study ID Numbers: LYMHD0002
Study First Received: November 9, 2001
Last Updated: August 2, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bleomycin
Doxorubicin
Cyclophosphamide
Prednisone
Vinblastine
Vincristine
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on April 16, 2014