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

This study has been completed.
Sponsor:
Information provided by:
Temple University
ClinicalTrials.gov Identifier:
NCT00002522
First received: November 1, 1999
Last updated: September 30, 2010
Last verified: September 2010
  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: syngeneic bone marrow transplantation
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Temple University:

Study Start Date: February 1993
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
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
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: NCT00002522

Locations
United States, Pennsylvania
Fox Chase - Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2442
Sponsors and Collaborators
Temple University
Investigators
Study Chair: Kenneth F. Mangan, MD, FACP Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Temple University Bone Marrow Transplant Program, Temple University Health Systems
ClinicalTrials.gov Identifier: NCT00002522     History of Changes
Other Study ID Numbers: CDR0000078283, TUHSC-2162, NCI-V93-0249
Study First Received: November 1, 1999
Last Updated: September 30, 2010
Health Authority: United States: Federal Government

Keywords provided by Temple University:
stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
stage III adult Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
recurrent adult Hodgkin lymphoma

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

ClinicalTrials.gov processed this record on July 20, 2014