Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00265889
First received: December 14, 2005
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Biological: filgrastim
Drug: busulfan
Drug: cyclophosphamide
Drug: etoposide
Drug: melphalan
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: one year after second transplant ] [ Designated as safety issue: No ]
    Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

  • Response Rate [ Time Frame: One year after second transplant ] [ Designated as safety issue: No ]
    Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as >/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

  • Number of Patients That Experience Pulmonary Toxicity [ Time Frame: One year after second transplant ] [ Designated as safety issue: Yes ]
    Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.


Enrollment: 42
Study Start Date: February 2002
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Poor Risk
Primary progressive, recurrent, or resistant relapse patients
Biological: filgrastim
480 mcg beginning day +5
Drug: busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
Drug: cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
Drug: etoposide
60 mg/kg, IV
Drug: melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation
Radiation: radiation therapy
radiation therapy
Experimental: Good Risk
First recurrence patients
Biological: filgrastim
480 mcg beginning day +5
Drug: busulfan
11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses
Drug: cyclophosphamide
60 mg/kg IV over 2 hours x 2 days
Drug: etoposide
60 mg/kg, IV
Drug: melphalan
150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.
Procedure: autologous-autologous tandem hematopoietic stem cell transplantation
autologous-autologous tandem hematopoietic stem cell transplantation
Radiation: radiation therapy
radiation therapy

Detailed Description:

OBJECTIVES:

Primary

  • Determine the 3-year progression-free survival of patients with progressive or recurrent Hodgkin's lymphoma treated with tandem autologous stem cell transplantation (2 courses of high-dose therapy with autologous stem cell rescue).
  • Determine the response rate in patients treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a pilot study. Patients are stratified according to risk (poor risk [primary progressive, recurrent, or resistant relapse] vs good risk [first recurrence]).

  • Salvage therapy (for patients with relapsed disease after achieving a previous complete response): Patients receive at least 2 courses of salvage chemotherapy or radiotherapy.
  • Autologous hematopoietic stem cell collection: Patients undergo autologous hematopoietic stem cell collection. Patients with an inadequate number of collected stem cells are removed from the study.
  • First preparative regimen: Patients receive high-dose melphalan IV continuously over 16 hours on day -1.
  • First autologous stem cell transplantation (SCT): Patients undergo autologous SCT on day 0. They also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover. At least 4-8 weeks later, patients proceed to second preparative regimen.
  • Second preparative regimen: Patients receive high-dose carmustine IV over 1-2 hours on days -6, -5, and -4, etoposide IV over 4 hours on day -3, and cyclophosphamide IV over 2 hours on day -2. Beginning 36-48 hours later, patients proceed to the second autologous SCT (day 0).
  • Second autologous SCT: Patients undergo second autologous SCT on day 0. Patients also receive filgrastim (G-CSF) IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 34 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria:

    • Disease progression during initial first line chemotherapy
    • Complete response lasting ≤ 90 days after induction
    • Partial response lasting ≤ 90 days after induction
    • First recurrence/progression with the duration of initial response ≤ 12 months after completion of chemotherapy NOTE: *There must be unequivocal radiological evidence of recurrent or progressive disease if biopsy was not obtained at time of disease recurrence/progression
  • No clonal abnormalities in marrow collection
  • Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days prior to stem cell collection
  • Must have adequate sections of original diagnostic specimen available for review

    • Needle aspirations or cytologies are not adequate
  • No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free ≥ 5 years)
  • No CNS involvement

PATIENT CHARACTERISTICS:

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Bilirubin ≤ 1.5 times upper limit of normal* (ULN) NOTE: *Unless due to Hodgkin's lymphoma

Renal

  • Creatinine clearance ≥ 60 mL/min
  • Creatinine ≤ 2.0 times ULN

Cardiovascular

  • Ejection fraction ≥ 45% by 2-D echocardiogram
  • No significant active cardiac disease

Pulmonary

  • Adequate pulmonary function
  • DLCO ≥ 45%

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
  • No known HIV or AIDS infection
  • No active bacterial, fungal, or viral infection
  • No medical condition that would preclude study treatment

PRIOR CONCURRENT THERAPY:

Chemotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265889

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Brian J. Bolwell, MD Cleveland Clinic Taussig Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00265889     History of Changes
Other Study ID Numbers: CCF5386, P30CA043703, CCF-5386
Study First Received: December 14, 2005
Results First Received: June 10, 2013
Last Updated: October 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:
recurrent adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Busulfan
Cyclophosphamide
Melphalan
Etoposide
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 16, 2014