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Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsored by: Fox Chase Cancer Center CCOP Research Base
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002522
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with relapsed or refractory Hodgkin's lymphoma.


Condition Intervention Phase
Lymphoma
Drug: cisplatin
Drug: cyclophosphamide
Drug: etoposide
Procedure: autologous bone marrow transplantation
Procedure: bone marrow ablation with stem cell support
Procedure: peripheral blood stem cell transplantation
Procedure: radiation therapy
Procedure: syngeneic bone marrow transplantation
Phase II

MedlinePlus related topics:   Bone Marrow Transplantation    Cancer    Hodgkin's Disease    Lymphoma   

ChemIDplus related topics:   Cyclophosphamide    Etoposide    Cisplatin    Etoposide phosphate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   HIGH-DOSE CYCLOPHOSPHAMIDE, ETOPOSIDE, AND CISPLATIN (CEP) WITH RESCUE BY AUTOLOGOUS BONE MARROW OR AUTOLOGOUS PERIPHERAL BLOOD STEM CELLS IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN'S DISEASE

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

Study Start Date:   February 1993

Detailed Description:

OBJECTIVES:

  • Determine the curative potential of high-dose cyclophosphamide, etoposide, and cisplatin (CEP) followed by syngeneic or autologous bone marrow and/or autologous peripheral blood stem cell (PBSC) rescue in patients with relapsed or refractory stage I-IV Hodgkin's lymphoma.
  • Determine the overall response rate and survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.
  • Determine the differences in the rate of engraftment, response, and survival of patients treated with bone marrow vs PBSC transplantation.
  • Determine the response rate and survival of patients treated with late consolidative radiotherapy after recovery from transplantation.
  • Determine the toxicity of late consolidative radiotherapy after recovery from transplantation in these patients.

OUTLINE: Syngeneic or autologous bone marrow and/or autologous peripheral blood stem cells (PBSC) are harvested. Syngeneic bone marrow transplantation is preferred for patients with a qualifying identical twin donor. Patients without a syngeneic donor who have a history of lymphomatous involvement of the bone marrow or are profoundly hypocellular undergo harvest of PBSC alone. Patients without a syngeneic donor who have no history of lymphomatous involvement of the bone marrow undergo harvest of autologous bone marrow or PBSC.

Patients receive conditioning comprising cyclophosphamide IV over 1 hour on days -6 to -3 and etoposide IV over 1 hour every 12 hours and cisplatin IV continuously on days -6 to -4. Bone marrow and/or PBSC are infused on day 0. (Patients requiring more than 25 bags of stem cells receive bone marrow transplantation on day 0 and PBSC transplantation on day 1.)

After recovery from transplantation, eligible patients receive consolidative radiotherapy to any site of prior bulk disease (greater than 5 cm) present at any time before transplantation and any site of disease present at the time of transplantation.

Patients are followed at 3, 6, and 12 months and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven stage I-IV Hodgkin's lymphoma
  • Must have refractory or relapsed disease, defined by 1 of the following:

    • Failure to achieve a complete remission (CR) after 4 courses of conventional-dose front-line chemotherapy
    • Disease in second or greater remission

      • Patients should be encouraged to undergo transplantation prior to a third salvage regimen
      • Patients previously treated with multiple regimens considered on a case-by-case basis
  • No chemoresistant disease, defined as active progression with tumor growth greater than 25% by volume during first-line chemotherapy

    • Patients who respond to second-line chemotherapy may be eligible
  • Stable residual masses after conventional-dose chemotherapy not considered treatment failures

    • Active (refractory or relapsed) disease must be proven histologically or documented by gallium nitrate uptake
  • Syngeneic marrow transplantation offered to patients with consenting identical twin donor
  • No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 15 to 60 (selected patients up to age 70 may be eligible)

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Absolute neutrophil count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • SGOT and SGPT less than 2 times upper limit of normal
  • Albumin greater than 3.0 g/dL

Renal:

  • Must meet 1 of the following criteria:

    • Creatinine less than 1.8 mg/dL
    • Creatinine clearance greater than 60 mL/min
    • BUN less than 20 mg/dL

Cardiovascular:

  • Left ventricular ejection fraction at least 50%

Pulmonary:

  • DLCO, FEV_1, and FVC greater than 50% of predicted OR
  • Resting pO_2 greater than 70 mm Hg on room air

Other:

  • HIV negative
  • No severe neurologic or emotional disorders
  • No active infection
  • No other disease that would limit life expectancy
  • Not pregnant
  • Fertile patients must use effective contraception
  • Adequate psychosocial support required

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002522

Locations
United States, Pennsylvania
Fox Chase - Temple Cancer Center    
      Philadelphia, Pennsylvania, United States, 19111-2442

Sponsors and Collaborators
Fox Chase Cancer Center CCOP Research Base

Investigators
Study Chair:     Kenneth F. Mangan, MD, FACP     Fox Chase Cancer Center CCOP Research Base    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000078283, TUHSC-2162, NCI-V93-0249
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002522
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult Hodgkin lymphoma  
stage II adult Hodgkin lymphoma  
stage III adult Hodgkin lymphoma  
stage IV adult Hodgkin lymphoma  
recurrent adult Hodgkin lymphoma  

Study placed in the following topic categories:
Lymphatic Diseases
Hodgkin's disease
Immunoproliferative Disorders
Cisplatin
Hodgkin lymphoma, adult
Cyclophosphamide
Lymphoproliferative Disorders
Etoposide phosphate
Etoposide
Hodgkin Disease
Lymphoma
Recurrence

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on September 16, 2008




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