Full Text View
Tabular View
No Study Results Posted
Related Studies
Immunotherapy Using Cyclosporine, Interferon Gamma, and Interleukin-2 After High-Dose Myeloablative Chemotherapy With Autologous Stem Cell Transplantation in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma
This study has been completed.
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Children's Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070187
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Giving immunotherapy using cyclosporine, interferon gamma, and interleukin-2 after stem cell transplantation may help the transplanted cells make an immune response and kill any remaining cancer cells. It is not yet known whether high-dose chemotherapy followed by autologous stem cell transplantation is more effective with or without immunotherapy.

PURPOSE: This randomized phase II/III trial is studying how well high-dose chemotherapy followed by autologous stem cell transplantation, cyclosporine, interferon gamma, and interleukin-2 works and compares it to high-dose chemotherapy followed by autologous stem cell transplantation only in treating patients with refractory or relapsed Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: aldesleukin
Biological: filgrastim
Biological: recombinant interferon gamma
Drug: carmustine
Drug: cyclosporine
Drug: cytarabine
Drug: etoposide
Drug: melphalan
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Phase II
Phase III

MedlinePlus related topics: Bone Marrow Transplantation Cancer Hodgkin's Disease Lymphoma
Drug Information available for: Cytarabine hydrochloride Etoposide Cyclosporine Cyclosporin Interferon gamma-1b Aldesleukin Filgrastim Cytarabine Melphalan Carmustine Interferons
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Phase II/III Study of Immunomodulation After High Dose Myeloablative Therapy With Autologous Stem Cell Rescue for Refractory/Relapsed Hodgkin Disease

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Event-free survival at 3 years after stem cell rescue [ Designated as safety issue: No ]
  • Overall survival at 3 years after stem cell rescue [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Non-relapse mortality at 100 days after stem cell rescue [ Designated as safety issue: No ]
  • Graft-vs-host disease at 100 days after stem cell rescue [ Designated as safety issue: No ]
  • T-lymphocyte activity at 100 days after stem cell rescue [ Designated as safety issue: No ]
  • Invariant peptide expression at 100 days after stem cell rescue [ Designated as safety issue: No ]

Study Start Date: November 2003
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of Hodgkin's lymphoma

    • Histologically confirmed at original diagnosis AND at relapse or disease progression
    • Relapsed or refractory to conventional therapy
  • No recurrence without B symptoms or bulky disease at least 1 year after completion of minimal systemic therapy defined by either of the following:

    • Stage IA/IIA with nodal disease previously treated with radiotherapy only
    • Stage IA/IIA with nodal disease previously treated with less than 3 courses of standard dose chemotherapy
  • Concurrently enrolled on the COG-AHOD00P1 salvage chemotherapy study OR received other appropriate salvage therapy (e.g., ifosfamide and vinorelbine)

PATIENT CHARACTERISTICS:

Age

  • Under 30

Performance status

  • ECOG 0-2 (for adults)
  • Lansky 50-100% (for children)

Life expectancy

  • At least 2 months

Hematopoietic

  • Absolute neutrophil count at least 500/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • SGPT less than 2.5 times normal

Renal

  • Creatinine no greater than 1.5 times normal OR
  • Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min/1.73 m^2

Cardiovascular

  • Shortening fraction at least 27% by echocardiogram OR
  • Ejection fraction at least 50% by MUGA

Pulmonary

  • No evidence of dyspnea at rest
  • No exercise intolerance
  • DLCO at least 50% (patients 8 years of age and over)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • No concurrent serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from prior immunotherapy
  • At least 1 week since prior antineoplastic biologic agents
  • More than 1 week since prior growth factors
  • No prior stem cell transplantation
  • No other concurrent immunomodulating agents

Chemotherapy

  • See Disease Characteristics
  • More than 2 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosoureas) and recovered
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • No concurrent steroids, including dexamethasone as an antiemetic

Radiotherapy

  • See Disease Characteristics
  • Recovered from prior radiotherapy

Surgery

  • Not specified

Other

  • No concurrent participation in another COG therapeutic study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070187

  Show 63 Study Locations
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Allen R. Chen, MD, PhD, MHS Sidney Kimmel Comprehensive Cancer Center
Investigator: Sharon L. Gardner, MD New York University School of Medicine
  More Information

Additional Information:
Publications:
Chen AR, Hutchison R, Hess A, et al.: Clinical outcomes of patients with recurrent/refractory Hodgkin disease receiving cyclosporine, interferon-, and interleukin-2 immunotherapy to induce auto-reactivity after autologous stem cell transplantation with BEAM: a COG study. [Abstract] Blood 110 (11): A-1896, 2007.

Study ID Numbers: CDR0000330135, COG-AHOD0121
Study First Received: October 3, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00070187     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma

Study placed in the following topic categories:
Antimetabolites
Melphalan
Cyclosporine
Interferon Type II
Immunologic Factors
Clotrimazole
Hodgkin Lymphoma, Childhood
Miconazole
Etoposide phosphate
Cyclosporins
Anti-Retroviral Agents
Antifungal Agents
Hodgkin Disease
Lymphoma
Etoposide
Alkylating Agents
Cytarabine
Anti-HIV Agents
Immunoproliferative Disorders
Hodgkin Lymphoma, Adult
Interferons
Carmustine
Tioconazole
Hodgkin's Disease
Antiviral Agents
Immunosuppressive Agents
Recurrence
Lymphatic Diseases
Aldesleukin
Interleukin-2

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Cyclosporine
Interferon Type II
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Cyclosporins
Anti-Retroviral Agents
Antifungal Agents
Therapeutic Uses
Dermatologic Agents
Lymphoma
Hodgkin Disease
Alkylating Agents
Cytarabine
Anti-HIV Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Interferons
Carmustine
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009