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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Ranjana Advani, Stanford University
ClinicalTrials.gov Identifier:
NCT00026208
First received: November 9, 2001
Last updated: March 2, 2017
Last verified: March 2017
  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: Intervention Model: Single Group Assignment
Masking: None (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 Ranjana Advani, Stanford University:

Primary Outcome Measures:
  • Progression-free survival by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]

Secondary Outcome Measures:
  • Early and late treatment-related toxicity [ Time Frame: Duration of study ]
  • Freedom from second disease progression by Kaplan-Meier [ Time Frame: at completion of therapy and then annually for 3 years ]
  • Overall survival by Kaplan-Meier [ Time Frame: at 5 and 10 years ]
  • Frequency of complete response by positron-emission tomography scan [ Time Frame: between weeks 4 and 5 of chemotherapy ]

Enrollment: 76
Study Start Date: June 2001
Study Completion Date: February 13, 2017
Primary Completion Date: February 13, 2017 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Ranjana Advani Stanford University
  More Information

Responsible Party: Ranjana Advani, Saul A. Rosenberg, MD, Professor of Lymphoma, Stanford University
ClinicalTrials.gov Identifier: NCT00026208     History of Changes
Other Study ID Numbers: LYMHD0002
IRB-13081 ( Other Identifier: Stanford IRB )
Study First Received: November 9, 2001
Last Updated: March 2, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisone
Vincristine
Doxorubicin
Bleomycin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on September 21, 2017