Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00255723
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow from the patient, may allow more chemotherapy to be given so that more cancer cells are killed. Giving combination chemotherapy together with radiation therapy before an autologous stem cell transplant may be an effective treatment for Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation therapy work in treating patients who are undergoing an autologous stem cell transplant for relapsed or refractory Hodgkin's lymphoma.

Condition or disease Intervention/treatment Phase
Lymphoma Drug: carboplatin Drug: etoposide Drug: ifosfamide Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Risk-Adapted High Dose Chemoradiotherapy and Autologous Stem Cell Transplantation for Patients With Relapsed and Primary Refractory Hodgkin's Lymphoma
Study Start Date : April 2004
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cytoreductive chemotherapy group 1
Patients receive ICE comprising ifosfamide IV and carboplatin IV once on day 2 and etoposide IV over 1 hour once daily on days 1-3. Patients then receive ifosfamide IV twice on day 15, carboplatin IV once on day 17 and etoposide IV over 1 hour twice daily on days 15-17.
Drug: carboplatin
Given IV

Drug: etoposide
Given IV

Drug: ifosfamide
Given IV

Experimental: Cytoreductive chemotherapy group 2
Patients receive ifosfamide IV twice on days 1 and 17, carboplatin IV once on days 3 and 19, and etoposide IV over 1 hour twice daily on days 1-3 and 17-19.
Drug: carboplatin
Given IV

Drug: etoposide
Given IV

Drug: ifosfamide
Given IV

Primary Outcome Measures :
  1. Overall Objective Response [ Time Frame: 3 years ]

    Overall objective response to therapy Complete remission/unconfirmed (CRu)

    This includes patients who meet criteria for CR with the following exceptions:

    1. A residual lymph node mass > 1.5 cm in the short axis with normalization of 18Ffluorodeoxyglucose- PET scan Partial remission/minimal response (PR and MR)

    1. Any decrease in lymph nodes and nodal-based masses
    2. Any decrease in PET avidity (however, residual FDG uptake is present)
    3. Involving organs involved prior to therapy must have diminished in size.
    4. No new sites of disease Stable disease Response is less than that which constitutes a PR and disease does not meet criteria for progressive disease Progressive disease

    1. Increase in lymph nodes or nodal-based masses, or other measurable disease from pretreatment observations. 2. Appearance of any new lesion at the end of therapy

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologic diagnosis of Classical Hodgkin's Lymphoma. Lymphocyte predominant histology will be excluded.
  • Primary refractory or relapsed disease proven by biopsy or fine needle aspiration (cytology) of an involved site
  • Failure of doxorubicin or nitrogen mustard containing front-line therapy
  • 18F-fluorodeoxyglucose-PET scan demonstrating PET avid disease
  • Cardiac ejection fraction of greater than 45%, measured since last chemotherapy.
  • Adjusted diffusing capacity of greater than 50% on pulmonary function testing, measured since last chemotherapy
  • Serum creatinine < than or = to 1.5 mg/dl; if creatinine >1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be >60 ml/minute.
  • ANC>1000/μl and Platelets>50,000/μl
  • Total bilirubin < than or = to 2.0 mg/dl in the absence of a history of Gilbert's disease.
  • Females of childbearing age must be on an acceptable form of birth control.
  • Age between 18 and 72
  • HIV I and II negative.
  • Patients or their guardians must be capable of providing informed consent.

Exclusion Criteria:

Histology for Lymphocyte predominant subtype Hodgkin's Lymphoma

  • Prior treatment with carboplatin, cisplatin, ifosfamide, gemcitabine, or vinorelbine
  • Hepatitis B surface antigen positive.
  • Known pregnancy or breast-feeding.
  • Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, will preclude administering chemotherapy safely.
  • History of any malignancy for which the disease-free interval is <5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00255723

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Craig Moskowitz, MD Memorial Sloan Kettering Cancer Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT00255723     History of Changes
Other Study ID Numbers: 04-047
First Posted: November 21, 2005    Key Record Dates
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016
Last Verified: December 2015

Keywords provided by Memorial Sloan Kettering Cancer Center:
adult lymphocyte depletion Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
recurrent adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide phosphate
Isophosphamide mustard
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents